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

Primary Purpose

Epidermolysis Bullosa

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Epidermolysis Bullosa focused on measuring dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: Epidermolysis bullosa Patient age: 2 months to 18 years

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Baylor College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004791
    Brief Title
    Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents With Epidermolysis Bullosa
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Baylor College of Medicine

    4. Oversight

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epidermolysis Bullosa
    Keywords
    dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease

    7. Study Design

    Enrollment
    15 (false)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: Epidermolysis bullosa Patient age: 2 months to 18 years
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William J. Klish
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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