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NCT03644693 · ClinicalTrials.gov registry record · NA
Nutritional Formulation for Angelman Syndrome
A NA study of Angelman Syndrome, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03644693: Completed NA study of Angelman Syndrome, sponsored by University of Colorado, Denver.
NCT03644693 is a NA study of Angelman Syndrome that has completed, run by University of Colorado, Denver. The registered enrollment target is 15 participants, below the 125-participant average among 11 other Angelman Syndrome trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03644693, a NA study of Angelman Syndrome, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Tolerability will be demonstrated through patient compliance with the protocol as determined by the amount as measured in grams per day of nutritional formulation consumed as compared to the amount prescribed.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Nutritional Formulation Containing Exogenous Ketones
- DIETARY_SUPPLEMENT Placebo Formulation
Study Locations (1)
Colorado
- Children's Hopsital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2020-01-15 |
| Phase | NA |
What the finished NCT03644693 record still lists
NCT03644693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 125-participant average among 11 other Angelman Syndrome trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Angelman Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Nutritional Formulation Containing Exogenous Ketones is the first listed.
NCT03644693 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03644693 about?
NCT03644693 is a clinical study titled "Nutritional Formulation for Angelman Syndrome". 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...
What is the current status of trial NCT03644693?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2018-11-01. Estimated completion is 2020-01-15.
What conditions does trial NCT03644693 study?
This clinical trial studies the following conditions: Angelman Syndrome.
What interventions are being tested in trial NCT03644693?
The interventions under investigation include: Nutritional Formulation Containing Exogenous Ketones (DIETARY_SUPPLEMENT), Placebo Formulation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03644693?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03644693 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Angelman Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03644693's enrollment target sits among peer trials
15 11th of 11 higher than 1 of 11 other Angelman Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Angelman Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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