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Completed

NCT Number: NCT05352373

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

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

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Key information

Conditions

Rett Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations X-Linked Intellectual Disability

Age range

5 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of Rett syndrome

Exclusion criteria

  • parathyroid disease
  • renal disease

Treatment and study plan

Calcium

Dietary Supplement

calcium carbonate

Placebo

Dietary Supplement

sodium bicarbonate

Primary outcomes

  1. Bone mineral content (BMC)

    Time frame: change from baseline to 1 year thereafter

    Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry

  2. Bone mineral density (BMD)

    Time frame: change from baseline to 1 year thereafter

    Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry

Secondary outcomes

  1. Osteocalcin

    Time frame: change from baseline to 1 year thereafter

    Serum Osteocalcin (ng/ml)

  2. Bone alkaline phosphatase

    Time frame: change from baseline to 1 year thereafter

    Serum Bone alkaline phosphatase (mcg/ml)

  3. C-telopeptide

    Time frame: change from baseline to 1 year thereafter

    Serum C-telopeptide (pg/ml)

  4. Calcium/creatinine ratio

    Time frame: change from baseline to 1 year thereafter

    Urinary calcium/creatinine ratio (mg/g)

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 28, 2022
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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