Actively Recruiting
Metformin in Children With Fragile X Syndrome
Led by Children's Hospital of Fudan University · Updated on 2025-02-18
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metformin in Children With Fragile X Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetic testing confirms the diagnosis of FXS
- Participation secured with informed consent from guardian
- Body mass index (BMI) above the 3rd percentile
- Taking no more than two therapeutic drugs
- Able to attend regular follow-up visits
You will not qualify if you...
- Malnutrition
- Primary heart disease
- Severe infection or acute clinical illness
- Gastrointestinal, renal, or hepatic disease
- Previous history of lactic acidosis
- Previous intolerance to metformin
- Use of angiotensin converting enzyme inhibitors, anticoagulants, or presence of vitamin B12 deficiency
- Alcohol consumption
- Unstable systemic diseases other than FXS
- Recent changes in clinical medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
Q
Qiong Xu, Phd MD
CONTACT
C
Chunchun Hu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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