Trial · NCT04984798

Vitamin E Efficacy in HI/HA

NCT04984798, Phase 2, Withdrawn, Children's Hospital of Philadelphia

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vitamin E Efficacy in HI/HA. Trials, record NCT04984798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04984798

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vitamin E Efficacy in HI/HA
NCT number: NCT04984798
Status: Withdrawn
Phases: Phase 2
Enrollment: 0 participants, actual
Lead sponsor: Children's Hospital of Philadelphia
Conditions: Hyperinsulinism-Hyperammonemia Syndrome
Interventions: Vitamin E
First posted: 2021-08-02
Last updated: 2022-12-13

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	protein-induced hyperinsulinemia	4-11 weeks	Change in plasma insulin concentration area under the curve (AUC) during leucine AIR test after vitamin E treatment compared to before.
Secondary	mean glucose concentration	4-11 weeks	Change in mean glucose concentration detected on continuous glucose monitor (CGM) during the study interval after vitamin E treatment compared to before.
Secondary	proportion of time spent with glucose <70 mg/dL	4-11 weeks	Change in proportion of time spent with glucose \<70 mg/dL, detected on continuous glucose monitor (CGM) during the study interval after vitamin E treatment compared to before.
Secondary	proportion of time spent with glucose <50 mg/dL	4-11 weeks	Change in proportion of time spent with glucose \<50 mg/dL, detected on continuous glucose monitor (CGM) during the study interval after vitamin E treatment compared to before.
Secondary	hypoglycemic episodes	4-11 weeks	Change in frequency of hypoglycemic episodes (plasma glucose \<70 mg/dL and plasma glucose \<50 mg/dL) detected on home glucose meter and/or continuous glucose monitor (CGM) after vitamin E treatment compared to before.
Secondary	protein-induced C-peptide release	4-11 weeks	Change in plasma C-peptide concentration area under the curve (AUC) during leucine AIR test after vitamin E treatment compared to before.
Secondary	vitamin E	4-11 weeks	Change in serum alpha-tocopherol concentration after vitamin E treatment compared to before.
Secondary	ammonia	4-11 weeks	Change in blood ammonia concentration after vitamin E treatment compared to before.
Secondary	seizures	4-11 weeks	Change in frequency of seizures, based on symptom questionnaire, after vitamin E treatment compared to before.
Other	number of participants with EEG abnormalities	8-11 weeks	Change in brain electrical activity after vitamin E treatment compared to before.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
940710	BACKGROUND	PubMed
8429120	BACKGROUND	PubMed
11241047	BACKGROUND	PubMed
11502802	BACKGROUND	PubMed
19531491	BACKGROUND	PubMed
20332361	BACKGROUND	PubMed
20936362	BACKGROUND	PubMed
23275527	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04984798

GET https://conductscience.org/api/trials/v1/NCT04984798/registered

API reference For AI assistants