MedTrace Logo

Liquid Valine and Isoleucine in Maple Syrup Urine Disease

NCT06581991 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-09-03

No results posted yet for this study

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 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Valine oral solution (50mg/ml) and isoleucine oral solution (25mg/ml)

Subjects will take valine oral solution (50mg/ml) in place of usual powdered valine supplement for 28 days. Subjects will then take isoleucine oral solution (25mg/ml) in place of their usual powdered isoleucine supplement for 28 days.

Sponsors & Collaborators

  • Birmingham Women's and Children's NHS Foundation Trust

    collaborator OTHER

  • Meta Healthcare Ltd

    lead INDUSTRY

Principal Investigators

  • Anita MacDonald · Birmingham Children's Hospital, UK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-09-30
Completion
2026-09-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06581991 on ClinicalTrials.gov