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NCT00004791 Clinical Trial

Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents With Epidermolysis Bullosa

Epidermolysis Bullosa Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004791
Other study ID # 199/11912
Secondary ID BCM-H3246
Status Completed
Phase N/A
First received February 24, 2000
Last updated June 23, 2005
Start date August 1995

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES: I. Characterize the nutritional and metabolic profile of children and adolescents with epidermolysis bullosa.

II. Determine patterns of body composition in these patients. III. Determine the energy requirements of these patients by measuring resting energy expenditure.

IV. Assess protein nutrition by measuring lean body mass.

Description:

PROTOCOL OUTLINE:

Data collected from a 5-day food diary are analyzed for protein, nutrient, and calorie intake. Nutritional, metabolic, and body composition are evaluated by indirect calorimetry, total body electrical conductivity, total body potassium, and lean body mass.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility PROTOCOL ENTRY CRITERIA:

- Epidermolysis bullosa

- Patient age: 2 months to 18 years

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Baylor College of Medicine
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Recruiting NCT01340235 - Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin Phase 3
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