Vitamin C Supplementation Intervention

February 17, 2021 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • UNCH Meadowmont Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention 1
Vitamin C 500 mg taken daily for 3 months
Dietary supplement: Vitamin C 500 mg
500 mg tablet taken orally with one meal daily
Other Names:
  • L-Ascorbic acid
EXPERIMENTAL: Intervention 2
Vitamin C 1000 mg taken daily for 3 months
Dietary supplement: Vitamin C 1000 mg
1000 mg tablet taken orally with one meal daily
Other Names:
  • L-Ascorbic acid
PLACEBO_COMPARATOR: Control
Placebo tablets taken daily for 3 months
Other: Placebo
1 tablet taken orally with one meal daily
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Vitamin C Level at Baseline
Time Frame: Baseline
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Baseline
Serum Vitamin C Level at Month 3
Time Frame: Month 3
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life Scores
Time Frame: Baseline and up to 3 months after enrollment
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
Total MSAS-HF Score
Time Frame: Baseline and up to 3 months after enrollment
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
Cardiac Function
Time Frame: Baseline and up to 3 months after enrollment
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
Oxidative Stress
Time Frame: Baseline and up to 3 months after enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Nursing Research (NINR)
Sigma Theta Tau International Honor Society of Nursing

Investigators

  • Principal Investigator: Jia-Rong Wu, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 14, 2018

Primary Completion (ACTUAL)

June 16, 2020

Study Completion (ACTUAL)

June 16, 2020

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (ACTUAL)

July 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-1809
  • T32NR007091 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial will be shared, after de-identification.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication from this trial.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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