Nutritional Aspects of Rett Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 1993

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004656 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Nutritional Aspects of Rett Syndrome

Official Title ^ICMJE

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.

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Rett Syndrome

Intervention ^ICMJE

Procedure: Metabolic assessment with body composition evaluation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

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

Gender

Female

Ages

5 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004656

Responsible Party

Study ID Numbers ^ICMJE

199/11814, BCM-CNRC-H1637

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Baylor College of Medicine

Investigators ^ICMJE

Study Chair:

Kathleen J. Motil

Baylor College of Medicine

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

February 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP