Status:
COMPLETED
Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis
Lead Sponsor:
Texas A&M University
Collaborating Sponsors:
Arkansas Children's Hospital Research Institute
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
10-21 years
Phase:
NA
Brief Summary
Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis (CF), negatively influencing their quality of life and survival. At the time of a diagnosis of CF, severe protei...
Detailed Description
In this study, we will test the following hypothesis: A high-leucine essential amino acid mixture (dose of 6.7 g) will stimulate protein anabolism to a greater extent than a standard balanced mixture ...
Eligibility Criteria
Inclusion
- Subjects who already have a diagnosis of CF based on universal diagnostic criteria.
- Age 14 to 21 years at the time of enrollment
- Under routine medical control at the CF center of ACH
- Admitted to the ACH for treatment of pulmonary exacerbation of CF disease.
- Improvement in lung function (FEV1) at the time of enrollment back to baseline values (as determined in the clinically stable pre-hospital period)
- Central or peripheral venous line in place
- No planned major changes or interventions in the treatment and care of the pediatric subject on Day -2 and -1 before discharge from the hospital.
Exclusion
- Established diagnosis of Diabetes Mellitus
- Presence of fever within the last 3 days
- Unstable metabolic diseases including liver (cirrhosis) or renal disease
- Chronic respiratory failure with cor pulmonale
- Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- Any other condition according to the principle investigator or study physician would interfere with collecting study samples
- Failure to give assent / informed consent
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01172301
Start Date
July 1 2008
End Date
February 1 2013
Last Update
August 11 2015
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205