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Recruiting Phase 4 NCT05120505

Metformin in Children With Fragile X Syndrome

Trial Parameters

Condition Fragile X Syndrome
Sponsor Children's Hospital of Fudan University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 20
Sex ALL
Min Age 2 Years
Max Age 16 Years
Start Date 2021-12-29
Completion 2025-12-30
Interventions
MetforminPlacebo

Brief Summary

This study is a controlled trial of metformin in children with fragile X syndrome(FXS). The age of FXS children range from 2 to 16 years old. Participants will be randomized in a double-blind design to either drug or placebo for 6-month period. The primary objectives are to assess metformin in treatment of behavior problems, cognitive and language with fragile X syndrome.

Eligibility Criteria

Inclusion Criteria: * Genetic testing confirms the diagnosis of FXS * Participate in the study with the informed consent of the guardian * BMI\>the 3rd percentile * Not taking more than 2 therapeutic drugs * Able to receive regular follow-up visits Exclusion Criteria: * Malnutrition * Primary heart disease * Severe infection or acute clinical illness * Gastrointestinal, renal, or hepatic disease * Previous history of lactic acidosis * previous use of metformin intolerant * Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption * Unstable systemic diseases other than FXS * Changes in clinical medication

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