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Completed

NCT Number: NCT06654089

A Study Evaluating Quality of Life Parameters Following Use of Emergen-C

The purpose of this study is to determine how Emergen-C use can improve quality of life (QoL) in a real-world setting to help consumers and healthcare professionals understand the benefits of taking Emergen-C on a routine or daily basis.

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Key information

Conditions

Dietary Supplements

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lindus Health Limited

New York, 10017, United States

About this study

This will be a randomized, double-blinded, placebo-controlled clinical trial to evaluate the over-time effects of 12-weeks Emergen-C supplementation on QoL parameters in a real-world setting. This study will be entirely decentralized, and participants will not be required to physically attend any on-site visits. All study data will be collected remotely through a study platform using the participant's personal mobile device, tablet or computer. Sufficient participants will be screened to enroll approximately 300 eligible participants (approximately 150 participants per group) and approximately 240 participants are expected to complete the study (approximately 120 participants per group).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant's provision of a signed and dated electronic informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Healthy adults, 18-64 years of age at the time of electronic consent (does not exclude any ethnicities, races, or gender identities).
  • Participant is seeking to improve their energy/less fatigue levels.
  • Participants whose baseline score is greater than or equal to (>=) 10 on the dimension of general fatigue of the MFI and a score >=3 for at least ten of the 20 questions of the MFI.
  • Participants who are willing and able to comply with all study related activities as shown in the Schedule of Activities.
  • Participants who reside in the United States (except for Hawaii and Alaska).
  • Participants who own a mobile device, tablet or computer with access to stable internet connection and are willing to use their device to complete study surveys and assessments.

Exclusion criteria

  • Participants who are either directly involved in the conduct of the study or a member of their immediate family; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
  • Participants who have participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
  • Participants who are pregnant, lactating, or plan to be pregnant or lactating during the course of the study (self-report).
  • Participants with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
  • Participants who are hypertensive or salt-sensitive should be excluded from this study.
  • Participants who report being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day).
  • Participants who are unable to read and understand English.
  • Participants who report current and/or recent (up to 3 months ago) major illnesses and/ or major surgery.
  • Participants who report a planned surgery during the study duration.
  • Participants who report a diagnosis of heart failure, heart rhythm disturbances, severe liver disease, severe mental health diagnosis, or severe renal failure.
  • Participants who report taking medications (in the previous 21 days) that have well established moderate or severe interaction with any of the study product ingredients: Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 milligrams (mg) per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, Monoamine Oxidase Inhibitors (MAOIs), or thyroid products.
  • Participants who are currently taking a multivitamin or have taken a multivitamin in the past 30 days and are not willing to stop taking a multivitamin for the duration of the trial.
  • Participants who are currently taking other Vitamin C or B supplements or have taken Vitamin C or B supplements in the past 30 days and are not willing to stop taking other Vitamin C or B supplements for the duration of the trial.
  • Participants who are currently consuming energy drinks or energy shots or have consumed an energy drink or energy shot in the past 30 days and are not willing to stop consuming energy drinks and energy shots for the duration of the trial.
  • A participant who has previously been enrolled in this study.
  • A participant who, in the opinion of the investigator or delegate, should not participate in the study.

Treatment and study plan

Emergen-C Core Super Orange Powder

Dietary Supplement

A dietary supplement powder containing vitamin C, zinc, vitamin B6, vitamin B12, folate, and manganese.

Placebo

Dietary Supplement

To ensure proper blinding, the placebo was formulated to be indistinguishable from Emergen-C in taste, appearance, and other sensory characteristics. The placebo therefore contained fructose, and the electrolytes potassium, magnesium, calcium, and sodium.

Primary outcomes

  1. Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12

    Time frame: Baseline and Week 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  2. Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12

    Time frame: Baseline and Week 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  3. Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12

    Time frame: Baseline and Week 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.

  4. Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12

    Time frame: Baseline and Week 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.

  5. Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12

    Time frame: Baseline and Week 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

Secondary outcomes

  1. Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8

    Time frame: Baseline, Week 4 and Week 8

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  2. Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8

    Time frame: Baseline, Week 4 and Week 8

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  3. Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8

    Time frame: Baseline, Week 4 and Week 8

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  4. Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8

    Time frame: Baseline, Week 4 and Week 8

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  5. Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8

    Time frame: Baseline, Week 4 and Week 8

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  6. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  7. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  8. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  9. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  10. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  11. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  12. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  13. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  14. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.

  15. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  16. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.

  17. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.

  18. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.

  19. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  20. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  21. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  22. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  23. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  24. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  25. Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition

    Time frame: Baseline, Weeks 4, 8 and 12

    The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.

  26. Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support

    Time frame: Baseline, Weeks 4, 8 and 12

    Participants answered 2 QoL questions related to Family support domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.

  27. Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience

    Time frame: Baseline, Weeks 4, 8 and 12

    Participants answered 2 QoL questions related to resilience domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.

  28. Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind

    Time frame: Baseline, Weeks 4, 8 and 12

    Participants answered 2 QoL questions related to 'Ability to relax and unwind' domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.

Sponsors and collaborators

Lead sponsor

HALEON

Industry

Registry information

Official study title

A Real-World Evidence Study Evaluating Quality of Life Parameters Following Use of Emergen-C

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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