Status:
TERMINATED
Effect of Glycine in Cystic Fibrosis
Lead Sponsor:
Instituto Nacional de Enfermedades Respiratorias
Collaborating Sponsors:
Hospital Infantil de Mexico Federico Gomez
Instituto Mexicano del Seguro Social
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5-15 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5 g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis, as compared wi...
Detailed Description
Background. Cystic fibrosis (CF) is a genetic disorder caused by a mutation in a gene that codifies for a chloride channel named "cystic fibrosis transmembrane regulator" (CFTR). In the lungs this res...
Eligibility Criteria
Inclusion
- Children of either sex
- Between 5 and 15 years of age
- With CF diagnosed according to established criteria
- Without changes in the CF treatment in the last 30 days
- Without CF exacerbation in the last 30 days
- Without acute respiratory infection (e.g., common cold) in the last 15 days
- Informed consent letter signed by their parents or legal guardians
Exclusion
- Children with CF that had participated in a research protocol in the last 3 months
- Presence of serious adverse effects attributable to glycine, in which case the result will be considered as therapeutic failure in the statistical analysis
- Development of a CF exacerbation, in which case the available data so far collected will be included in the statistical analysis
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01417481
Start Date
March 1 2012
End Date
September 1 2013
Last Update
November 5 2014
Active Locations (3)
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1
Hospital Infantil de México
Mexico City, Mexico, 06720
2
Unidad de Investigación Médica en Enfermedades Respiratorias, Hospital de Pediatría, CMN SXXI, IMSS
Mexico City, Mexico, 06720
3
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico, 14080