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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 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.

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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.

Interventions

  • DIETARY_SUPPLEMENT Modified Atkins diet

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2021-04-01
Est. Completion 2025-03-12
Phase Early Phase 1

What the Registry Record Tells You About NCT04722315

The ClinicalTrials.gov registry entry for NCT04722315 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Modified Atkins diet is the first listed.

NCT04722315 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.