N/A
Completed N=36
Vitamin C Supplementation Intervention
Heart Failure
Source: ClinicalTrials.gov NCT04036110 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Serum Vitamin C Level at Baseline — 13372; 16079; 13111 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Vitamin C Level at Baseline |
13372; 16079; 13111 | — |
| PRIMARY Serum Vitamin C Level at Month 3 |
21309; 20574; 12537 | — |
| SECONDARY Health Related Quality of Life Scores |
45.3; 31.4; 44.2; 68.2; 47.4; 27.6 | — |
| SECONDARY Total MSAS-HF Score |
47.5; 20.2; 31.2; 24.5; 24.8; 20.1 | — |
| SECONDARY Cardiac Function |
6.9; 5.6; 12.7; 14.2 | — |
| SECONDARY Oxidative Stress |
23144; 10406; 13832; 507; 2431; 2580 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT04036110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.