Vitamin C Supplementation Intervention

Heart Failure Clinical Trial

Official title:

Vitamin C Supplementation Intervention for Patients With Heart Failure-A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036110
• Other study ID #: 17-1809
• Secondary ID: T32NR007091
• Status: Completed
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: June 16, 2020

Study information

• Verified date: September 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Vitamin C 500 mg
500 mg tablet taken orally with one meal daily
• Vitamin C 1000 mg
1000 mg tablet taken orally with one meal daily

Other:
• Placebo
1 tablet taken orally with one meal daily

Locations

Country	Name	City	State
United States	UNCH Meadowmont Clinic	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Nursing Research (NINR), Sigma Theta Tau International Honor Society of Nursing

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Vitamin C Level at Baseline	The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum	Baseline
Primary	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	Health Related Quality of Life Scores	Health related quality of life is measured using the Minnesota Living with Heart Failure questionnaire (MLHFQ). The MLHFQ is a patient-reported outcome to measure the patient's perceptions of the influence of heart failure on physical and emotional aspects of life. The questionnaire has 21 items to assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and emotional functions. The response scale for all 21 items on the MLHFQ is based on a 6-point (from 0 to 5). Scores are summed to a range of 0-105, in which with higher scores indicate worse health-related quality of life. Measured at Baseline and Month 3.	Baseline and up to 3 months after enrollment
Secondary	Total MSAS-HF Score	Symptom burden is measured using items from the Memorial Symptom Assessment Scale-Heart Failure (MSAS-HF). The MSAS-HF is an 8-item questionnaire to measure HF symptoms experienced by patients with HF. Patients will be first asked if the symptom was present during the previous 7 days. If present, three characteristics of each symptom will be rated: frequency of symptom, severity of symptom, and degree of symptom distress. Frequency is rated on a scale from 0 to 5 (1=no symptom to 5=all the time), severity rated on a scale from 0 to 5 (0=not at all to 5=extremely) and distress rated on a scale from 0 to 5 (0=not at all to 5=extremely). Burden score for each symptom can range from 0 (no burden) to 4 (greatest symptom frequency, severity, and distress). The total MAS-HF scores are summed to a range of 0-180, with higher scores indicating higher symptom burden. Measured at Baseline and Month 3.	Baseline and up to 3 months after enrollment
Secondary	Cardiac Function	The MindWare Mobile impedance cardiograph (model number 50-2303-00) used to measure participant's cardiac function using the parameter of cardiac output. Measured at Baseline and Month 3.	Baseline and up to 3 months after enrollment
Secondary	Oxidative Stress	The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify 8-iso-PGF2a isoprostane in serum to reflect oxidative stress. Measured at Baseline and Month 3.	Baseline and up to 3 months after enrollment