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Vitamin C Supplementation Intervention

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin C 500 mg
Vitamin C 1000 mg
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Vitamin C supplementation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNCH Meadowmont Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Intervention 1

Intervention 2

Control

Arm Description

Vitamin C 500 mg taken daily for 3 months

Vitamin C 1000 mg taken daily for 3 months

Placebo tablets taken daily for 3 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 25, 2019
Last Updated
February 17, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Sigma Theta Tau International Honor Society of Nursing, National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04036110
Brief Title
Vitamin C Supplementation Intervention
Official Title
Vitamin C Supplementation Intervention for Patients With Heart Failure-A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Sigma Theta Tau International Honor Society of Nursing, National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Vitamin C supplementation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
Vitamin C 500 mg taken daily for 3 months
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
Vitamin C 1000 mg taken daily for 3 months
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo tablets taken daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C 500 mg
Other Intervention Name(s)
L-Ascorbic acid
Intervention Description
500 mg tablet taken orally with one meal daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C 1000 mg
Other Intervention Name(s)
L-Ascorbic acid
Intervention Description
1000 mg tablet taken orally with one meal daily
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
1 tablet taken orally with one meal daily
Primary Outcome Measure Information:
Title
Serum Vitamin C Level at Baseline
Description
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Time Frame
Baseline
Title
Serum Vitamin C Level at Month 3
Description
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Health Related Quality of Life Scores
Description
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.
Time Frame
Baseline and up to 3 months after enrollment
Title
Total MSAS-HF Score
Description
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.
Time Frame
Baseline and up to 3 months after enrollment
Title
Cardiac Function
Description
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.
Time Frame
Baseline and up to 3 months after enrollment
Title
Oxidative Stress
Description
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.
Time Frame
Baseline and up to 3 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Rong Wu, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNCH Meadowmont Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25360419
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.
Results Reference
background
PubMed Identifier
11336107
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.
Results Reference
background

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Vitamin C Supplementation Intervention

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