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

April 27, 2022 updated by: Kathleen J Motil, Baylor College of Medicine
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • clinical diagnosis of Rett syndrome

Exclusion Criteria

  • parathyroid disease
  • renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline to 1 year thereafter
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
change from baseline to 1 year thereafter

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Kathleen J Motil, MD, PHD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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