Metformin in Children With Fragile X Syndrome
Efficacy and Safety of Metformin in the Treatment of Fragile X Syndrome
Children's Hospital of Fudan University
20 participants
Dec 29, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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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Interventions
The patients in this group will be obtain Metformin starting from 50mg everyday at night, and gradually increase to maximum tolerable dose of 1-2g per day according to weights of patients for 6 months.
The patients in this group will be obtain starch tablets (which had same appearance and size comparing to Metformin) starting from 50mg everyday to 1-2g per day according to weights of patients for 6 months.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05120505