An interventional study of calcium and placebo in Rett Syndrome, sponsored by Baylor College of Medicine. Completed. Open to female participants aged 5 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome
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.
470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year
Dietary Supplement: calcium
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
Dietary Supplement: placebo
calcium carbonate
sodium bicarbonate
Bone mineral content (BMC)
Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry
Time frame: change from baseline to 1 year thereafter
Bone mineral density (BMD)
Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry
Time frame: change from baseline to 1 year thereafter
Osteocalcin
Serum Osteocalcin (ng/ml)
Time frame: change from baseline to 1 year thereafter
Bone alkaline phosphatase
Serum Bone alkaline phosphatase (mcg/ml)
Time frame: change from baseline to 1 year thereafter
C-telopeptide
Serum C-telopeptide (pg/ml)
Time frame: change from baseline to 1 year thereafter
Calcium/creatinine ratio
Urinary calcium/creatinine ratio (mg/g)
Time frame: change from baseline to 1 year thereafter
No study locations are listed for this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine