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Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome

NCT03797222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-11-25

Study results available
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Summary

Investigators will assess the tolerability of oral Vitamin E supplementation in subjects with congenital hyperinsulinism (HI) and hyperammonemia (HA) syndrome.

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.

Sponsors & Collaborators

  • University of Pennsylvania

    collaborator OTHER

  • Lawson Wilkins Pediatric Endocrine Society

    collaborator OTHER

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

    collaborator NIH

  • Elizabeth A Rosenfeld

    lead OTHER

Principal Investigators

  • Elizabeth Rosenfeld, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2020-03-23
Completion
2020-03-23

Countries

  • United States

Study Locations

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Entities

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 NCT03797222 on ClinicalTrials.gov