Viewing Study NCT02021526



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Study NCT ID: NCT02021526
Status: WITHDRAWN
Last Update Posted: 2019-02-15
First Post: 2013-12-12

Brief Title: Triheptanoin C7 Oil a Food Supplement for Glucose Transporter Type I Deficiency G1D
Sponsor: Juan Pascual
Organization: University of Texas Southwestern Medical Center

Study Overview

Official Title: Treatment Development of Triheptanoin for Glucose Transporter Type I Deficiency
Status: WITHDRAWN
Status Verified Date: 2019-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: NIH funding resulted in new clinical trial
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a single-site open-label phase II trial of C7 a food supplement or medical food for the development of treatment outcome measures for glucose transporter type I deficiency G1D The primary outcome measures are 1 Safety and tolerability of C7 as measured by changes in comprehensive blood work including lipid and free fatty acid panels self-reported side effects and clinical exam 2 Changes in brain metabolic rate by MRI and EEG measurements during C7 treatment and 3 Maintenance of ketosis in G1D patients on ketogenic diet as measured by serial ketone levels during treatment initiation
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None