Your session is about to expire
← Back to Search
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 belowSelect...
My Kaposi's sarcoma diagnosis follows the latest consensus criteria.
Select...
My genetic test shows a mutation in the KMT2D gene.
Select...
I am 18 or older with a confirmed diagnosis of Kabuki syndrome type 1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 weeks for 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 weeks for 12 weeks
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 moreSecondary 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that makes the modified Atkins diet unsafe for me.My Kaposi's sarcoma diagnosis follows the latest consensus criteria.My genetic test shows a mutation in the KMT2D gene.I am 18 or older with a confirmed diagnosis of Kabuki syndrome type 1.I cannot travel to Baltimore for two appointments 12 weeks apart.I have been diagnosed with a genetic syndrome.I'm sorry, but the criterion you provided appears to be incomplete. Can you please provide more context or information?
Research Study Groups:
This trial has the following groups:- Group 1: MAD diet group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Share this study with friends
Copy Link
Messenger