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Vitamin E for Hyperinsulinism-Hyperammonemia Syndrome

Phase 2

Waitlist Available

Led By Amanda M Ackermann, MD, PhD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-11 weeks

Awards & highlights

Study Summary

This trial is testing whether vitamin E can help treat congenital hyperinsulinism (HI), a disorder that causes persistent and severe hypoglycemia starting at birth. HI/HA syndrome is the second most common type of congenital HI and is caused by activating mutations in glutamate dehydrogenase (GDH).

Eligible Conditions

Hyperinsulinism-Hyperammonemia Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-11 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-11 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

protein-induced hyperinsulinemia

Secondary outcome measures

ammonia

hypoglycemic episodes

mean glucose concentration

+5 more

Other outcome measures

brain glutamate

number of participants with EEG abnormalities

Side effects data

From 2021 Phase 4 trial • 31 Patients • NCT03176966

hepatic encephalopathy

bruising

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin E

Ropinirole

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vitamin E Dose-EscalationExperimental Treatment1 Intervention

Subjects will take an oral Vitamin E (dl-alpha-tocopherol) supplement twice daily with a fat-containing meal for 6-9 weeks. The dose will be increased every 2-3 weeks over the course of the study (initial dose 600 IU twice daily, next dose 1,200 IU twice daily, final dose 2,400 IU twice daily). Formulations include softgel capsules in 200, 400, and 1,000 IU doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin E

2003

Completed Phase 4

~94880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

707 Previous Clinical Trials

8,581,291 Total Patients Enrolled

University of PennsylvaniaOTHER

1,998 Previous Clinical Trials

42,879,381 Total Patients Enrolled

1 Trials studying Hyperinsulinism-Hyperammonemia Syndrome

14 Patients Enrolled for Hyperinsulinism-Hyperammonemia Syndrome

Lawson Wilkins Pediatric Endocrine SocietyOTHER

2 Previous Clinical Trials

124 Total Patients Enrolled

1 Trials studying Hyperinsulinism-Hyperammonemia Syndrome

14 Patients Enrolled for Hyperinsulinism-Hyperammonemia Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research initiatives that have focused on Vitamin E?

"At present, 12 clinical trials related to Vitamin E are being conducted with 3 of them in the final stage. Most research is based out of Salt Lake City; however, 30 sites across the nation are collaborating on these studies."

Answered by AI

What are the chief therapeutic applications of Vitamin E?

"Vitamin E is an effective remedy for long-chain omega-3 fatty acid supplementation, a lack of necessary vitamins in the diet, and dietary supplementation."

Answered by AI

How many individuals have been recruited for this trial thus far?

"At this juncture, the trial is no longer seeking applicants. It was posted on November 1st 2022 and last edited on August 17th 2022. If you are looking for alternative trials to participate in, there are 1398 studies currently accepting participants with hyperinsulinism and 12 that use Vitamin E as a treatment option."

Answered by AI

Does this trial have any current availabilities for participants?

"This trial is no longer actively seeking patients; the posting was first made on November 1st 2022 and subsequently updated for the last time August 17th of that same year. If you are looking for other clinical trials, 1398 research studies for hyperinsulinism and 12 Vitamin E-related projects are currently recruiting participants."

Answered by AI