Vitamin C Supplementation Intervention

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2020-06-16

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention 1

Vitamin C 500 mg taken daily for 3 months

Group Type EXPERIMENTAL

Vitamin C 500 mg

Intervention Type DIETARY_SUPPLEMENT

500 mg tablet taken orally with one meal daily

Intervention 2

Vitamin C 1000 mg taken daily for 3 months

Group Type EXPERIMENTAL

Vitamin C 1000 mg

Intervention Type DIETARY_SUPPLEMENT

1000 mg tablet taken orally with one meal daily

Control

Placebo tablets taken daily for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 tablet taken orally with one meal daily

Interventions

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Vitamin C 500 mg

500 mg tablet taken orally with one meal daily

Intervention Type DIETARY_SUPPLEMENT

Vitamin C 1000 mg

1000 mg tablet taken orally with one meal daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 tablet taken orally with one meal daily

Intervention Type OTHER

Other Intervention Names

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L-Ascorbic acid L-Ascorbic acid Sugar pill

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No