NCT05352373

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

April 15, 2022

Last Update Submit

April 27, 2022

Conditions

Rett Syndrome

Keywords

Low bone mass

Outcome Measures

Primary Outcomes (2)

  • Bone mineral content (BMC)

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

    change from baseline to 1 year thereafter

  • Bone mineral density (BMD)

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

    change from baseline to 1 year thereafter

Secondary Outcomes (4)

  • Osteocalcin

    change from baseline to 1 year thereafter

  • Bone alkaline phosphatase

    change from baseline to 1 year thereafter

  • C-telopeptide

    change from baseline to 1 year thereafter

  • Calcium/creatinine ratio

    change from baseline to 1 year thereafter

Study Arms (2)

Rett Active Supplement

ACTIVE COMPARATOR

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

Rett Placebo Supplement

PLACEBO COMPARATOR

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

Interventions

calciumDIETARY_SUPPLEMENT

calcium carbonate

Rett Active Supplement
placeboDIETARY_SUPPLEMENT

sodium bicarbonate

Rett Placebo Supplement

Eligibility Criteria

Age5 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • clinical diagnosis of Rett syndrome

You may not qualify if:

  • parathyroid disease
  • renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rett Syndrome

Interventions

Calcium

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Kathleen J Motil, MD, PHD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, double blind
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 28, 2022

Study Start

March 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 28, 2022

Record last verified: 2022-04