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Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D

NCT03301532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-01-17

Study results available
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Summary

To explore triheptanoin (C7 oil) compatibility with the ketogenic diet by evaluating EEG, and seizure rate, glycemia and ketosis in proven G1D patients receiving a ketogenic diet.

Conditions

  • GLUT1DS1

Interventions

DRUG

Triheptanoin

Dietary supplementation with triheptanoin

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Juan Pascual, M.D. · Study Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Months
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2021-06-18
Completion
2022-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03301532 on ClinicalTrials.gov