Vitamin C Supplementation Intervention
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2018
CompletedFirst Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2020
CompletedResults Posted
Study results publicly available
January 11, 2021
CompletedMarch 9, 2021
September 1, 2020
1.8 years
July 25, 2019
December 15, 2020
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum Vitamin C Level at Baseline
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Baseline
Serum Vitamin C Level at Month 3
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Month 3
Secondary Outcomes (4)
Health Related Quality of Life Scores
Baseline and up to 3 months after enrollment
Total MSAS-HF Score
Baseline and up to 3 months after enrollment
Cardiac Function
Baseline and up to 3 months after enrollment
Oxidative Stress
Baseline and up to 3 months after enrollment
Study Arms (3)
Intervention 1
EXPERIMENTALVitamin C 500 mg taken daily for 3 months
Intervention 2
EXPERIMENTALVitamin C 1000 mg taken daily for 3 months
Control
PLACEBO COMPARATORPlacebo tablets taken daily for 3 months
Interventions
500 mg tablet taken orally with one meal daily
1000 mg tablet taken orally with one meal daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNCH Meadowmont Clinic
Chapel Hill, North Carolina, 27517, United States
Related Publications (2)
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.
PMID: 25360419BACKGROUNDEllis 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.
PMID: 11336107BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jia-Rong Wu, PhD, RN
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Jia-Rong Wu, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2019
First Posted
July 29, 2019
Study Start
August 14, 2018
Primary Completion
June 16, 2020
Study Completion
June 16, 2020
Last Updated
March 9, 2021
Results First Posted
January 11, 2021
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 9 months and ending 36 months following article publication from this trial.
- Access Criteria
- Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
All of the individual participant data collected during the trial will be shared, after de-identification.