The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome

Not Applicable

Completed

• Conditions: Rett Syndrome
• Interventions: Dietary Supplement: placebo; Dietary Supplement: calcium

• 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.

Study Timeline

• Study Start: 2008-03-01
• Primary Completion: 2012-03-01
• Study Completion: 2012-03-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-27
• Last Update Submitted: 2022-04-27
• Study First Posted: 2022-04-28
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rett Placebo Supplement	placebo	Females with clinical diagnosis of Rett syndrome treated orally daily with sodium bicarbonate, dose based on equivalent weight for active supplement for age, for one year
Rett Active Supplement	calcium	Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year

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)