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Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients

NCT00974025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-06-01

No results posted yet for this study

Summary

In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved exercise tolerance and endothelial function in patients who have undergone the Fontan operation, compared to placebo.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin C

High-dose Vitamin C will be administered in 4 age-based dosing groups

DIETARY_SUPPLEMENT

Placebo

Placebo will be administered twice daily for four weeks

Sponsors & Collaborators

  • Griese-Hutchinson Champions for Children's Hearts Investigator Award

    collaborator UNKNOWN

  • University of Michigan

    lead OTHER

Principal Investigators

  • John R Charpie, MD · University of Michigan

  • Bryan H Goldstein, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-11-30
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00974025 on ClinicalTrials.gov