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NCT04722315 · ClinicalTrials.gov registry record · Early Phase 1
Study of Modified Atkins Diet in Kabuki Syndrome
A Early Phase 1 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT04722315: Completed Early Phase 1 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT04722315 is a Early Phase 1 study that has completed, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722315, a Early Phase 1 study, has completed, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Animal models of Kabuki syndrome have showed a reversal of the cognitive phenotype with ketogenic diet. Modified Atkins diet is safer and easier tolerated than full ketogenic diet and still has the histone deacetylase inhibition believed to be responsible for the cognitive improvement. This study aims to examine a small number of adults with Kabuki syndrome before and after 12 weeks on a modified Atkins diet to determine if there is any cognitive improvement and if the diet can be tolerated.
Primary Outcome
Established measure to determine visuospatial perception. There are 30 items and each item is worth 1 point. Will assess change in score from baseline to post-diet. A higher score indicates a better performance (range 0-30).
Interventions
- DIETARY_SUPPLEMENT Modified Atkins diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2025-03-12 |
| Phase | Early Phase 1 |
What the finished NCT04722315 record still lists
NCT04722315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Modified Atkins diet is the first listed.
NCT04722315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04722315 about?
NCT04722315 is a clinical study titled "Study of Modified Atkins Diet in Kabuki Syndrome". Animal models of Kabuki syndrome have showed a reversal of the cognitive phenotype with ketogenic diet. Modified Atkins diet is safer and easier tolerated than full ketogenic diet and still has the histone deacetylase inhibition believed to be responsible for the cognitive improvement. This study ai...
What is the current status of trial NCT04722315?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2021-04-01. Estimated completion is 2025-03-12.
What interventions are being tested in trial NCT04722315?
The interventions under investigation include: Modified Atkins diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04722315?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04722315's enrollment target sits among peer trials
10 1628th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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