CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Vitamin Edietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03797222
NCT03797222N/ACompleted
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Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome

Elizabeth A Rosenfeld·interventional·Posted Jan 9, 2019·Updated Nov 25, 2022

In Brief

A clinical study evaluating Vitamin E for Hyperinsulinism-Hyperammonemia Syndrome. Completed, enrolled 14 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperinsulinism-Hyperammonemia Syndrome
CountriesUnited States
CollaboratorsUniversity of Pennsylvania, Lawson Wilkins Pediatric Endocrine Society, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 9, 2019
Enrollment StartApr 15, 2019
Primary CompletionMar 23, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.5 years ago

Interventions

Vitamin Edietary

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.