Vitamin C Supplementation Intervention

University of North Carolina (UNC)

Status: Completed

Conditions: Heart Failure

Treatments: Dietary Supplement: Vitamin C 500 mg; Other: Placebo; Dietary Supplement: Vitamin C 1000 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04036110

17-1809

T32NR007091 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups, including a placebo group

Intervention 1

Experimental group

Description:

Vitamin C 500 mg taken daily for 3 months

Treatment:

Dietary Supplement: Vitamin C 500 mg

Intervention 2

Experimental group

Description:

Vitamin C 1000 mg taken daily for 3 months

Treatment:

Dietary Supplement: Vitamin C 1000 mg

Control

Placebo Comparator group

Description:

Placebo tablets taken daily for 3 months

Treatment:

Other: Placebo