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Completed

NCT Number: NCT04036110

Vitamin C Supplementation Intervention

This study is to test a low-cost, simple vitamin C supplementation intervention, that is, comparing placebo to 500 mg/day vitamin C and 1 gram/day vitamin C daily to assess feasibility and acceptability of vitamin C supplementation and effects on serum vitamin C level, health-related quality of life (HRQOL), symptom burden, oxidative stress, and cardiac function.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNCH Meadowmont Clinic

Chapel Hill, North Carolina, 27517, United States

About this study

This study will address feasibility from the perspective of being able to: a) to detect significant differences in the serum vitamin C level after supplementation (3 months) between the intervention groups and the control group, b) to detect significant differences in health related quality of life (HRQOL), symptom burden, oxidative stress, and cardiac function after vitamin C supplementation (3 months) between the intervention groups and the control group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patents recruited will have a diagnosis of chronic HF, either preserved or reduced ejection fraction. The diagnosis and etiology of chronic HF will be confirmed by a HF cardiologist using established criteria.

Other criteria:

  • have undergone evaluation of HF and optimization of medical therapy,
  • vitamin C supplementation <500 mg/day
  • have not been referred for heart transplantation,
  • able to read and speak English,
  • >1 month from any inpatient hospitalization

Exclusion criteria

  • history of renal stones or renal disease (serum creatinine >1.5,
  • history of glucose-6-phosphate dehydrogenase deficiency (G6PD) and cognitive impairment that precludes giving informed consent or ability to follow protocol instructions
  • pregnant

Treatment and study plan

Vitamin C 500 mg

Dietary Supplement

500 mg tablet taken orally with one meal daily

Other names: L-Ascorbic acid

Vitamin C 1000 mg

Dietary Supplement

1000 mg tablet taken orally with one meal daily

Other names: L-Ascorbic acid

Placebo

Other

1 tablet taken orally with one meal daily

Other names: Sugar pill

Primary outcomes

  1. Serum Vitamin C Level at Baseline

    Time frame: Baseline

    The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum

  2. Serum Vitamin C Level at Month 3

    Time frame: Month 3

    The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum

Secondary outcomes

  1. Health Related Quality of Life Scores

    Time frame: Baseline and up to 3 months after enrollment

    Health related quality of life is measured using the Minnesota Living with Heart Failure questionnaire (MLHFQ). The MLHFQ is a patient-reported outcome to measure the patient's perceptions of the influence of heart failure on physical and emotional aspects of life. The questionnaire has 21 items to assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and emotional functions. The response scale for all 21 items on the MLHFQ is based on a 6-point (from 0 to 5). Scores are summed to a range of 0-105, in which with higher scores indicate worse health-related quality of life. Measured at Baseline and Month 3.

  2. Total MSAS-HF Score

    Time frame: Baseline and up to 3 months after enrollment

    Symptom burden is measured using items from the Memorial Symptom Assessment Scale-Heart Failure (MSAS-HF). The MSAS-HF is an 8-item questionnaire to measure HF symptoms experienced by patients with HF. Patients will be first asked if the symptom was present during the previous 7 days. If present, three characteristics of each symptom will be rated: frequency of symptom, severity of symptom, and degree of symptom distress. Frequency is rated on a scale from 0 to 5 (1=no symptom to 5=all the time), severity rated on a scale from 0 to 5 (0=not at all to 5=extremely) and distress rated on a scale from 0 to 5 (0=not at all to 5=extremely). Burden score for each symptom can range from 0 (no burden) to 4 (greatest symptom frequency, severity, and distress). The total MAS-HF scores are summed to a range of 0-180, with higher scores indicating higher symptom burden. Measured at Baseline and Month 3.

  3. Cardiac Function

    Time frame: Baseline and up to 3 months after enrollment

    The MindWare Mobile impedance cardiograph (model number 50-2303-00) used to measure participant's cardiac function using the parameter of cardiac output. Measured at Baseline and Month 3.

  4. Oxidative Stress

    Time frame: Baseline and up to 3 months after enrollment

    The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify 8-iso-PGF2a isoprostane in serum to reflect oxidative stress. Measured at Baseline and Month 3.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • Sigma Theta Tau International Honor Society of Nursing

Registry information

Official study title

Vitamin C Supplementation Intervention for Patients With Heart Failure-A Pilot Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2019
Registry last updated
Mar 9, 2021

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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