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Vitamin C Supplementation Intervention

University of North Carolina (UNC) logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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