Clinical trial NCT04036110: Vitamin C Supplementation Intervention
Official title: Vitamin C Supplementation Intervention for Patients With Heart Failure-A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Vitamin C supplementation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International Honor Society of Nursing
name: National Institute of Nursing Research (NINR)
First posted: 2019-07-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

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 \<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

Primary outcomes:
measure: Serum Vitamin C Level at Baseline
timeFrame: Baseline
measure: Serum Vitamin C Level at Month 3
timeFrame: Month 3
Secondary outcomes:
measure: Health Related Quality of Life Scores
timeFrame: Baseline and up to 3 months after enrollment
measure: Total MSAS-HF Score
timeFrame: Baseline and up to 3 months after enrollment
measure: Cardiac Function
timeFrame: Baseline and up to 3 months after enrollment
measure: Oxidative Stress
timeFrame: Baseline and up to 3 months after enrollment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNCH Meadowmont Clinic
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jia-Rong Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carr AC, Vissers MC, Cook JS. The effect of intravenous vitamin C on cancer- and chemotherapy-related fatigue and quality of life. Front Oncol. 2014 Oct 16;4:283. doi: 10.3389/fonc.2014.00283. eCollection 2014.
citation: Ellis GR, Anderson RA, Chirkov YY, Morris-Thurgood J, Jackson SK, Lewis MJ, Horowitz JD, Frenneaux MP. Acute effects of vitamin C on platelet responsiveness to nitric oxide donors and endothelial function in patients with chronic heart failure. J Cardiovasc Pharmacol. 2001 May;37(5):564-70. doi: 10.1097/00005344-200105000-00008.