Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-05 @ 12:02 AM
Study NCT ID:
NCT03644693
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2018-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Formulation for Angelman Syndrome
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Tolerability of a Nutritional Formulation in Angelman Syndrome
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FANS
Brief Summary:
Low carbohydrate diets such as the ketogenic (KD) and low glycemic index (LGIT) diets have been shown to be effective in treating drug resistant seizures in children with Angelman syndrome (AS). The investigators hypothesize that consuming a fat based nutritional formulation with an exogenous ketone throughout the day will produce urinary ketosis in children consuming both low and high carbohydrate diets, depending upon dietary background. The nutritional formulation will provide fuel substrates that push metabolism away from carbohydrates and towards fat utilization. This research is being done to assess the safety and tolerability of a nutritional formulation for use in dietary interventions in AS.
Detailed Description:
An evaluation of the safety and tolerability of a nutritional formulation in Angelman syndrome in children ages 4-11 years.
Study is conducted over 16 weeks:
2 week baseline period - Patient continues on current dietary regimen they were on before joining the study (standard, ketogenic, or LGIT).
4 week intervention period - Patient consumes either placebo or nutritional formulation for 4 weeks, maintaining their current diet.
4 week washout period - Patient continues on current dietary regimen without consuming any study formulations.
4 week intervention period - Patient consumes either placebo or nutritional formulation for 4 weeks (crossover), maintaining their current diet.
2 week washout period - Patient continues on current dietary regimen without consuming any study formulations.
Follow-up phone call to be conducted by study personnel during this time.
Data is captured by the investigator during baseline, intervention, and washout periods, and by the parent/caregiver daily throughout the protocol using apps loaded on a provided tablet.
Study is conducted over 16 weeks:
2 week baseline period - Patient continues on current dietary regimen they were on before joining the study (standard, ketogenic, or LGIT).
4 week intervention period - Patient consumes either placebo or nutritional formulation for 4 weeks, maintaining their current diet.
4 week washout period - Patient continues on current dietary regimen without consuming any study formulations.
4 week intervention period - Patient consumes either placebo or nutritional formulation for 4 weeks (crossover), maintaining their current diet.
2 week washout period - Patient continues on current dietary regimen without consuming any study formulations.
Follow-up phone call to be conducted by study personnel during this time.
Data is captured by the investigator during baseline, intervention, and washout periods, and by the parent/caregiver daily throughout the protocol using apps loaded on a provided tablet.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: