Vitamin C Supplementation Intervention

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Placebo; Dietary Supplement: Vitamin C 1000 mg; Dietary Supplement: Vitamin C 500 mg

• Registration Number: NCT04036110
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-08-14
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Primary Completion: 2020-06-16
• Study Completion: 2020-06-16
• Status Verified: 2020-09
• Results First Submitted: 2020-12-15
• Results First Submitted QC: 2020-12-15
• Results First Posted: 2021-01-11
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo tablets taken daily for 3 months
Intervention 2	Vitamin C 1000 mg	Vitamin C 1000 mg taken daily for 3 months
Intervention 1	Vitamin C 500 mg	Vitamin C 500 mg taken daily for 3 months

Primary Outcome Measures

Name	Time	Method
Serum Vitamin C Level at Baseline	Baseline	The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Serum Vitamin C Level at Month 3	Month 3	The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum

Secondary Outcome Measures

Name	Time	Method
Total MSAS-HF Score	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.
Health Related Quality of Life Scores	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.
Cardiac Function	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.
Oxidative Stress	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.

Trial Locations

Locations (1)

UNCH Meadowmont Clinic; 🇺🇸 Chapel Hill, North Carolina, United States