Vitamin C Supplementation Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Vitamin C 500 mg
* Dietary Supplement: Vitamin C 1000 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 1<br>Vitamin C 500 mg taken daily for 3 months | Dietary Supplement: Vitamin C 500 mg<br>* 500 mg tablet taken orally with one meal daily<br>* Other names: L-Ascorbic acid;|
| Experimental: Intervention 2<br>Vitamin C 1000 mg taken daily for 3 months | Dietary Supplement: Vitamin C 1000 mg<br>* 1000 mg tablet taken orally with one meal daily<br>* Other names: L-Ascorbic acid;|
| Placebo Comparator: Control<br>Placebo tablets taken daily for 3 months | Other: Placebo<br>* 1 tablet taken orally with one meal daily<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Vitamin C Level at Baseline | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum | Baseline | 
| Serum Vitamin C Level at Month 3 | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life Scores | 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. | Baseline and up to 3 months after enrollment | 
| Total MSAS-HF Score | 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. | Baseline and up to 3 months after enrollment | 
| Cardiac Function | 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. | Baseline and up to 3 months after enrollment | 
| Oxidative Stress | 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. | Baseline and up to 3 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C supplementation