Liquid Valine and Isoleucine in Maple Syrup Urine Disease
ConditionMaple Syrup Urine Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-16
SponsorMeta Healthcare Ltd
About this trial
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 for a 56 day trial, of a new ready-to-use valine supplement and a new ready-to-use isoleucine supplement, to evaluate the tolerability and acceptability of the study products compared with their usual products.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Valine oral solution (50mg/ml) and isoleucine oral solution (25mg/ml)
Treatment groups
5 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Meta Healthcare Ltd
Lead sponsor
Birmingham Women's and Children's NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov