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

Primary Purpose

Rett Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
calcium
placebo
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rett Syndrome focused on measuring Low bone mass

Eligibility Criteria

5 Years - 30 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

  • clinical diagnosis of Rett syndrome

Exclusion Criteria

  • parathyroid disease
  • renal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Rett Active Supplement

    Rett Placebo Supplement

    Arm Description

    Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Osteocalcin
    Serum Osteocalcin (ng/ml)
    Bone alkaline phosphatase
    Serum Bone alkaline phosphatase (mcg/ml)
    C-telopeptide
    Serum C-telopeptide (pg/ml)
    Calcium/creatinine ratio
    Urinary calcium/creatinine ratio (mg/g)

    Full Information

    First Posted
    April 15, 2022
    Last Updated
    April 27, 2022
    Sponsor
    Baylor College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05352373
    Brief Title
    The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
    Official Title
    The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2008 (Actual)
    Primary Completion Date
    March 1, 2012 (Actual)
    Study Completion Date
    March 1, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baylor College of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rett Syndrome
    Keywords
    Low bone mass

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized, double blind
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rett Active Supplement
    Arm Type
    Active Comparator
    Arm Description
    Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year
    Arm Title
    Rett Placebo Supplement
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    calcium
    Intervention Description
    calcium carbonate
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    sodium bicarbonate
    Primary Outcome Measure Information:
    Title
    Bone mineral content (BMC)
    Description
    Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry
    Time Frame
    change from baseline to 1 year thereafter
    Title
    Bone mineral density (BMD)
    Description
    Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry
    Time Frame
    change from baseline to 1 year thereafter
    Secondary Outcome Measure Information:
    Title
    Osteocalcin
    Description
    Serum Osteocalcin (ng/ml)
    Time Frame
    change from baseline to 1 year thereafter
    Title
    Bone alkaline phosphatase
    Description
    Serum Bone alkaline phosphatase (mcg/ml)
    Time Frame
    change from baseline to 1 year thereafter
    Title
    C-telopeptide
    Description
    Serum C-telopeptide (pg/ml)
    Time Frame
    change from baseline to 1 year thereafter
    Title
    Calcium/creatinine ratio
    Description
    Urinary calcium/creatinine ratio (mg/g)
    Time Frame
    change from baseline to 1 year thereafter

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria clinical diagnosis of Rett syndrome Exclusion Criteria parathyroid disease renal disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen J Motil, MD, PHD
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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