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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rett Active Supplement | Active Comparator | Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year |
|
| Rett Placebo Supplement | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium | Dietary Supplement | calcium carbonate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral content (BMC) | Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry | change from baseline to 1 year thereafter |
| Bone mineral density (BMD) | Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry | change from baseline to 1 year thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Osteocalcin | Serum Osteocalcin (ng/ml) | change from baseline to 1 year thereafter |
| Bone alkaline phosphatase | Serum Bone alkaline phosphatase (mcg/ml) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen J Motil, MD, PHD | Baylor College of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D015518 | Rett Syndrome |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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randomized, double blind
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| placebo |
| Dietary Supplement |
sodium bicarbonate |
|
| change from baseline to 1 year thereafter |
| C-telopeptide | Serum C-telopeptide (pg/ml) | change from baseline to 1 year thereafter |
| Calcium/creatinine ratio | Urinary calcium/creatinine ratio (mg/g) | change from baseline to 1 year thereafter |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |