NCT00004656

Brief Summary

OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in healthy controls. II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining, sitting, and standing, by whole-room indirect calorimetry and isotope dilution. III. Quantify activity patterns by time-motion studies using 24-hour activity records and 12-hour videotaping. IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term oxygen consumption. V. Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by clinical anthropometry, whole-body potassium counting, and total-body electrical conductance. VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.

Trial Health

100
On Track

Trial Health Score

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

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1993

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1999

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Rett Syndrome

Keywords

Rett syndromeneurologic and psychiatric disordersrare disease

Interventions

Metabolic assessment with body composition evaluationPROCEDURE

Eligibility Criteria

Age5 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
PROTOCOL ENTRY CRITERIA: Patients aged 5 to 18 with Rett syndrome Able to sleep and awaken alone

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Rett SyndromeNeurologic ManifestationsMental DisordersRare Diseases

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeredodegenerative Disorders, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Kathleen J. Motil

    Baylor College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

May 1, 1993

Last Updated

June 24, 2005

Record last verified: 1999-02