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NCT Number: NCT03071796

Influences of Multivitamin Supplementation on Health Parameters

In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system.

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Key information

Conditions

Health Behavior Behavior

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Halle-Wittenberg

Halle, 06120, Germany

About this study

The double-blind, randomized intervention study is conducted for 12 weeks and includes two groups (placebo versus verum) with same number of participants.

The investigator aims to determine the effects of multivitamin supplement on blood and vital parameters which includes blood pressure, pulse, heart rate, variability of heart rate, vitamin D, vitamin B12, folic acid, homocysteine, HbA1c. Furthermore the investigator will access life quality, mood and perception of stress through the following questionnaire POMS, PSS-10, SF12 & SF36. The investigator will evaluate whether the multivitamin supplement changes the frequency of diseases like cold which represents the function of the immune system.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy women and men
  • age between 30-60 years
  • employed

Exclusion criteria

  • acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis)
  • frequent use of alcohol, drugs or cigarettes (>5 cigarettes / day)
  • use of additional supplements
  • use of medications (e.g. antihypertensive medications, lipid reducers, thyroid medication)

Treatment and study plan

Multivitamin supplement

Dietary Supplement

supplement includes 97 natural extracts

Placebo

Dietary Supplement

liquids with similar appearance and taste like multivitamin supplement for 12 weeks

Primary outcomes

  1. Plasma concentration of Vitamin B12

    Time frame: change measures (baseline to 12 weeks)

    vitamin B12 [pmol/l]

Secondary outcomes

  1. Analysis of blood pressure

    Time frame: change measures (baseline to 12 weeks)

    blood pressure

  2. Analysis of heart rate variability

    Time frame: change measures (baseline to 12 weeks)

    heart rate variability

  3. Analysis of speed of pulse wave,

    Time frame: change measures (baseline to 12 weeks)

    speed of pulse wave

  4. Plasma concentration of 25-hydroxyvitamin D

    Time frame: change measures (baseline to 12 weeks)

    25-hydroxyvitamin D [nmol/l]

  5. Plasma concentration of folic acid

    Time frame: change measures (baseline to 12 weeks)

    folic acid [nmol/l]

  6. Plasma concentration of homocysteine

    Time frame: change measures (baseline to 12 weeks)

    homocysteine [µmol/l]

  7. Plasma concentration of HbA1c

    Time frame: change measures (baseline to 12 weeks)

    HbA1c [mmol]

Other outcomes

  1. Susceptibility to infections

    Time frame: up to 12 weeks

    Documentation of diseases in disease diary

  2. assessment of life quality

    Time frame: change measures (baseline to 12 weeks)

    use of questionnaires SF-36

  3. assessment of mood

    Time frame: change measures (baseline to 12 weeks)

    use of questionnaires POMS

  4. assessment of perceived stress

    Time frame: change measures (baseline to 12 weeks)

    use of questionnaires PSS-10

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2017
Registry last updated
Jun 23, 2017

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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