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

Rett Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352373
• Other study ID #: H-19205
• Status: Completed
• Phase: N/A
• Start date: March 1, 2008
• Est. completion date: March 1, 2012

Study information

• Verified date: April 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 1, 2012
• Est. primary completion date: March 1, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 5 Years to 30 Years

Eligibility

Inclusion Criteria

• clinical diagnosis of Rett syndrome

Exclusion Criteria

• parathyroid disease

• renal disease

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Rett Syndrome
• Syndrome

Intervention

Dietary Supplement:
• calcium
calcium carbonate
• placebo
sodium bicarbonate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral content (BMC)	Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry	change from baseline to 1 year thereafter
Primary	Bone mineral density (BMD)	Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry	change from baseline to 1 year thereafter
Secondary	Osteocalcin	Serum Osteocalcin (ng/ml)	change from baseline to 1 year thereafter
Secondary	Bone alkaline phosphatase	Serum Bone alkaline phosphatase (mcg/ml)	change from baseline to 1 year thereafter
Secondary	C-telopeptide	Serum C-telopeptide (pg/ml)	change from baseline to 1 year thereafter
Secondary	Calcium/creatinine ratio	Urinary calcium/creatinine ratio (mg/g)	change from baseline to 1 year thereafter