Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00004656
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Aspects of Rett Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BCM-CNRC-H1637 | None | None | View |