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Dietary Supplement

Modified Atkins Diet for Kabuki Syndrome

Phase < 1
Waitlist Available
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of KS will be made based on recently published consensus diagnosis criteria
Genetic confirmation of a pathogenic mutation in KMT2D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 weeks for 12 weeks
Awards & highlights

Study Summary

This trial will study if the ketogenic diet can help improve cognitive function in adults with Kabuki syndrome, and if the diet is tolerable for this population.

Who is the study for?
This trial is for adults over 18 with Kabuki syndrome type 1, confirmed both clinically and genetically. Participants must be able to follow a modified Atkins diet and travel to Baltimore twice over 12 weeks. Those with health issues that make the diet risky or another genetic syndrome cannot join.Check my eligibility
What is being tested?
The study tests if a modified Atkins diet can improve cognitive function in adults with Kabuki syndrome. It's based on animal studies showing benefits from ketogenic diets. Over 12 weeks, participants will switch to this safer, more tolerable diet variant.See study design
What are the potential side effects?
While not specified here, potential side effects of a modified Atkins diet may include fatigue, headache, constipation or other digestive changes initially as the body adapts to lower carbohydrate intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Kaposi's sarcoma diagnosis follows the latest consensus criteria.
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My genetic test shows a mutation in the KMT2D gene.
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I am 18 or older with a confirmed diagnosis of Kabuki syndrome type 1.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 weeks for 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 weeks for 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Beery Developmental Test of Visual Motor Integration
Beery Developmental Test of Visual Perception
Benton Judgement of Line Orientation
+4 more
Secondary outcome measures
Caregiver behavior rating scales: GAS-ID
DNA Methylation analysis

Trial Design

1Treatment groups
Experimental Treatment
Group I: MAD diet groupExperimental Treatment1 Intervention
15 adult participants with confirmed KMT2D pathogenic mutations. Baseline labs and education about Modified Atkins Diet. Then 12 weeks on a Modified Atkins Diet. Weekly urine dips for ketones and diet logs. Blood draw every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modified Atkins diet
2013
Completed Phase 3
~230

Find a Location

Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,953 Total Patients Enrolled

Media Library

Modified Atkins diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04722315 — Phase < 1
Kabuki Syndrome Research Study Groups: MAD diet group
Kabuki Syndrome Clinical Trial 2023: Modified Atkins diet Highlights & Side Effects. Trial Name: NCT04722315 — Phase < 1
Modified Atkins diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722315 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial currently available?

"Affirmative. As per the records on clinicaltrials.gov, this trial is actively seeking participants and launched on April 1st 2021 with a recent update taking place in November 17th 2022. The study requires 15 individuals from one medical centre to take part."

Answered by AI

How many participants are currently involved in this experiment?

"Affirmative, according to clinicaltrials.gov, this medical trial is presently recruiting participants. Initially posted on April 1st 2021 and most recently edited on November 17th 2022, the study requires 15 patients from one single site."

Answered by AI
~4 spots leftby Mar 2025