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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05352373

Enrollment

Registered

2022-04-28

Start date

2008-03-01

Completion date

2012-03-01

Last updated

2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rett Syndrome

Keywords

Low bone mass

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.

Interventions

DIETARY_SUPPLEMENTcalcium

calcium carbonate

DIETARY_SUPPLEMENTplacebo

sodium bicarbonate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

randomized, double blind

Eligibility

Sex/Gender

FEMALE

Age

5 Years to 30 Years

Healthy volunteers

Inclusion criteria

* clinical diagnosis of Rett syndrome

Exclusion criteria

* parathyroid disease * renal disease

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Osteocalcin	change from baseline to 1 year thereafter	Serum Osteocalcin (ng/ml)
Bone alkaline phosphatase	change from baseline to 1 year thereafter	Serum Bone alkaline phosphatase (mcg/ml)
C-telopeptide	change from baseline to 1 year thereafter	Serum C-telopeptide (pg/ml)
Calcium/creatinine ratio	change from baseline to 1 year thereafter	Urinary calcium/creatinine ratio (mg/g)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026