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

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ClinicalTrials.gov Identifier: NCT05352373
Recruitment Status : Completed
First Posted : April 28, 2022
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Kathleen J Motil, Baylor College of Medicine

Study Description
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Brief Summary:
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome

Condition or disease Intervention/treatment Phase
Rett Syndrome Dietary Supplement: calcium Dietary Supplement: placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double blind
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
Actual Study Start Date : March 1, 2008
Actual Primary Completion Date : March 1, 2012
Actual Study Completion Date : March 1, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Rett Active Supplement
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
calcium carbonate
Placebo Comparator: Rett Placebo Supplement
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
sodium bicarbonate


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • clinical diagnosis of Rett syndrome

Exclusion Criteria

  • parathyroid disease
  • renal disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05352373


Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Kathleen J Motil, MD, PHD Baylor College of Medicine
More Information
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Responsible Party: Kathleen J Motil, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05352373    
Other Study ID Numbers: H-19205
First Posted: April 28, 2022    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen J Motil, Baylor College of Medicine:
Low bone mass
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Rett Syndrome
Syndrome
Disease
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Mental Retardation, X-Linked
Intellectual Disability
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs