NCT00974025

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

September 9, 2009

Last Update Submit

May 31, 2017

Conditions

Fontan ProcedureHypoplastic Left Heart SyndromeTricuspid Atresia

Outcome Measures

Primary Outcomes (1)

  • Change in peak oxygen consumption (from baseline to post-study drug testing)

    4 weeks

Secondary Outcomes (6)

  • Oxygen Pulse

    4 weeks

  • Peak Work

    4 weeks

  • Endo-PAT score

    4 weeks

  • Framingham Modified Endothelial Function Score

    4 weeks

  • PedsQL 4.0 - quality of life assessment

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin CDIETARY_SUPPLEMENT

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

Vitamin C
PlaceboDIETARY_SUPPLEMENT

Placebo will be administered twice daily for four weeks

Placebo

Eligibility Criteria

Age8 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • Fontan-palliated patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • Goldstein BH, Golbus JR, Sandelin AM, Warnke N, Gooding L, King KK, Donohue JE, Gurney JG, Goldberg CS, Rocchini AP, Charpie JR. Usefulness of peripheral vascular function to predict functional health status in patients with Fontan circulation. Am J Cardiol. 2011 Aug 1;108(3):428-34. doi: 10.1016/j.amjcard.2011.03.064. Epub 2011 May 19.

    PMID: 21600541RESULT

  • Goldstein BH, Sandelin AM, Golbus JR, Warnke N, Gooding L, King KK, Donohue JE, Yu S, Gurney JG, Goldberg CS, Rocchini AP, Charpie JR. Impact of vitamin C on endothelial function and exercise capacity in patients with a Fontan circulation. Congenit Heart Dis. 2012 May-Jun;7(3):226-34. doi: 10.1111/j.1747-0803.2011.00605.x. Epub 2011 Dec 18.

    PMID: 22176653DERIVED

MeSH Terms

Conditions

Hypoplastic Left Heart SyndromeTricuspid Atresia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • John R Charpie, MD

    University of Michigan

    STUDY DIRECTOR

  • Bryan H Goldstein, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

June 1, 2009

Primary Completion

November 1, 2009

Study Completion

March 1, 2010

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations

US(1)