NCT02948244

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

Effect of Creatine Monohydrate on Functional Muscle Strength and Muscle Mass in Children With FSHD: a Multi-centre, Randomised, Double-blind Placebo-controlled Crossover Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-10-31
• Primary completion: 2021-01-31
• Completion: 2022-07-01
• First posted: 2016-10-28
• Last updated: 2023-02-08

Locations

1 site across 1 country: Australia