Status:
COMPLETED
Vitamin C Supplementation Intervention
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Sigma Theta Tau International Honor Society of Nursing
National Institute of Nursing Research (NINR)
Conditions:
Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
NA
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 acceptabili...
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04036110
Start Date
August 14 2018
End Date
June 16 2020
Last Update
March 9 2021
Active Locations (1)
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1
UNCH Meadowmont Clinic
Chapel Hill, North Carolina, United States, 27517