Nutritional Aspects of Rett Syndrome

NCT ID: NCT00004656

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1993-05-31

Brief Summary

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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.

Detailed Description

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PROTOCOL OUTLINE:

All participants undergo extensive nutritional and metabolic assessment with body composition evaluation. Studies include macronutrient intake, body fat, lean muscle mass, metabolic rate, and time-action studies; and 24-hour cardiac telemetry. Rett syndrome girls also receive a hemogram and hand x-ray.

Conditions

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Rett Syndrome

Keywords

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Rett syndrome neurologic and psychiatric disorders rare disease

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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Metabolic assessment with body composition evaluation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

Patients aged 5 to 18 with Rett syndrome Able to sleep and awaken alone
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Principal Investigators

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Kathleen J. Motil

Role: STUDY_CHAIR

Baylor College of Medicine

Other Identifiers

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BCM-CNRC-H1637

Identifier Type: -

Identifier Source: secondary_id

199/11814

Identifier Type: -

Identifier Source: org_study_id