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Effect of Creatine Monohydrate on Functional Muscle Strength in Children With FSHD

NCT02948244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-02-08

No results posted yet for this study

Summary

This multi-centre, randomised, double-blind, placebo-controlled crossover trial will compare changes in strength-related motor function following treatment with creatine monohydrate to treatment with placebo, as measured by the Motor Function Measure, from baseline to 12 weeks. Eligible subjects will undergo baseline assessments then will be randomised to either creatine monohydrate therapy or placebo for three months, followed by a six week wash-out period, then crossover to a further three months of therapy with either placebo or creatine. Subjects will undergo clinical assessments and study safety assessments at the beginning and end of each treatment period. The study will begin recruitment in early 2017.

Conditions

  • Facio-Scapulo-Humeral Dystrophy
  • FSHD2
  • FSHD1

Interventions

DIETARY_SUPPLEMENT

Creatine Monohydrate

Synthetically produced dietary supplement Creatine Monohydrate will be used in powder form reconstituted to a drink. The dosage will be 100mg/kg/day up to a maximum of 10 grams daily.

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Ian R Woodcock, MBBS · Murdoch Children Research Institute/Royal Children Hospital, Melbourne

  • Monique M Ryan · Murdoch Children Research Institute/Royal Children Hospital, Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2021-01-31
Completion
2022-07-01

Countries

  • Australia

Study Locations

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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 NCT02948244 on ClinicalTrials.gov