Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

April 15, 2019

Primary Completion Date

March 23, 2020

Study Completion Date

March 23, 2020

Conditions
Hyperinsulinism-Hyperammonemia Syndrome
Interventions
DIETARY_SUPPLEMENT

Vitamin E

Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if \>17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive \<600 IU daily, or for any subjects who prefer liquid medication to capsules.

Trial Locations (1)

19104

Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
collaborator

University of Pennsylvania

OTHER

collaborator

Lawson Wilkins Pediatric Endocrine Society

OTHER

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Elizabeth A Rosenfeld

OTHER

NCT03797222 - Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome | Biotech Hunter | Biotech Hunter