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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Vitamin C Supplementation on Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases

NCT06789640

Congenital Heart Disease (CHD)

NOT_YET_RECRUITING NA

Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development

NCT00479479

Vitamin B 12 Deficiency

COMPLETED NA

Effect of Parental Peri-conceptional Vitamin B12 Supplementation on Infant Neurocognitive Development in Offspring

NCT03088189

Neurodevelopmental Disorders

TERMINATED

Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants

NCT03876704

Vitamin A Deficiency Vitamin D Deficiency Vitamin E Deficiency +4 more

UNKNOWN PHASE3

Effectiveness of Vitamin C Supplementation in Treatment of Rickets

NCT05310760

Nutritional Rickets Bone Turnover Rate Disorder

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Recent evidence suggests that after Fontan operation, single ventricle patients have impaired function of the vascular endothelium due in part to abnormalities in nitric oxide signaling. Endothelial dysfunction may contribute to the development of congestive heart failure and exercise intolerance that have been well-documented in Fontan patients. Therapeutic interventions to improve endothelial function in adults with heart failure have mainly focused on increasing the synthesis or decreasing the degradation of nitric oxide. We propose a randomized, prospective, placebo-controlled trial of vitamin C, an antioxidant that protects NO deactivation, in subjects with single ventricular anatomy after Fontan palliation. The specific aims of this study are to compare NO signaling, endothelial function and exercise capacity in Fontan subjects to that of a control group that is frequency-matched to case subjects by age and sex, and to assess NO signaling, endothelial function and exercise capacity in Fontan subjects after 4 weeks of oral vitamin C (or placebo) therapy. These results have particular importance because improving the endothelial response in Fontan patients has the potential to reduce the risk of developing congestive heart failure and improve exercise capacity. Furthermore, assessing endothelial function and the effects of therapies aimed at improving vascular health may be generalizable to many other chronic pediatric conditions associated with increased cardiovascular risk such as obesity, diabetes mellitus, and hypertension.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fontan Procedure Hypoplastic Left Heart Syndrome Tricuspid Atresia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin C

High-dose Vitamin C in 4 age-based doses will be given in two-daily doses for four weeks

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo will be given in two-daily doses for four weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo will be administered twice daily for four weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin C

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo will be administered twice daily for four weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 8-25 years of age
* Fontan-palliated patient

Exclusion Criteria

* New York Heart Association (NYHA) classes III or IV
* Diabetes mellitus
* Family history of premature coronary artery disease
* Use of Sildenafil or other pulmonary artery vasodilators
* Prior cardiac arrest (outside the first 24-hours postoperatively)
* Life-threatening dysrhythmias
* Severe ventricular dysfunction
* Severe AV valve regurgitation
* Pregnancy
* Severe renal or hepatic impairment

Minimum Eligible Age

8 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes