Status:
NOT_YET_RECRUITING
Liquid Valine and Isoleucine in Maple Syrup Urine Disease
Lead Sponsor:
Meta Healthcare Ltd
Collaborating Sponsors:
Birmingham Women's and Children's NHS Foundation Trust
Conditions:
Maple Syrup Urine Disease
Eligibility:
All Genders
12-16 years
Phase:
NA
Brief Summary
This is a prospective, observational research study in 5 children with Maple Syrup Urine Disease (MSUD). Subjects who are currently taking a valine and isoleucine supplement for MSUD will be recruited...
Detailed Description
This is a prospective, observational 2-part research study in 5 children with Maple Syrup Urine Disease (MSUD). Subjects who are currently taking a valine and isoleucine supplement for MSUD will be re...
Eligibility Criteria
Inclusion
- Male and female MSUD patients ≥1 year and \<16 years of age.
- Patients diagnosed with MSUD.
- Taking both valine and isoleucine supplements for MSUD and willing to take the new supplements for 56 days.
- Absence of comorbidities.
- Adherence with dietary management and valine and isoleucine supplements.
- Able to understand and comply with the requirements of the investigation and sign the Informed Consent Form/Assent form
Exclusion
- Age \<1 year old and \>16 years old.
- Patients with comorbidities.
- Any moderate to severe acute illness which in the opinion of the Investigator would interfere with the study procedures or study outcome.
- History of poor co-operation, non-adherence with dietary management, or poor adherence to investigation procedures.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06581991
Start Date
October 1 2024
End Date
September 1 2026
Last Update
September 3 2024
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