The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
- Conditions
- Rett Syndrome
- Registration Number
- NCT05352373
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome
- Detailed Description
Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT).
Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Bone mineral content (BMC) change from baseline to 1 year thereafter Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry
Bone mineral density (BMD) change from baseline to 1 year thereafter Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry
- Secondary Outcome Measures
Name Time Method C-telopeptide change from baseline to 1 year thereafter Serum C-telopeptide (pg/ml)
Osteocalcin change from baseline to 1 year thereafter Serum Osteocalcin (ng/ml)
Calcium/creatinine ratio change from baseline to 1 year thereafter Urinary calcium/creatinine ratio (mg/g)
Bone alkaline phosphatase change from baseline to 1 year thereafter Serum Bone alkaline phosphatase (mcg/ml)