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Effect of Glycine in Cystic Fibrosis

NCT01417481 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2014-11-05

Study results available
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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 with placebo. During all of the study children will receive their usual treatment for cystic fibrosis.

Conditions

Interventions

DIETARY_SUPPLEMENT

Glycine

Daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks

DIETARY_SUPPLEMENT

Placebo

Daily oral administration of placebo (sugar glass) at a dose of 0.5 g/kg divided in three doses during 8 weeks

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    collaborator OTHER

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Instituto Nacional de Enfermedades Respiratorias

    lead OTHER_GOV

Principal Investigators

  • Mario H Vargas, MD, MSc · Instituto Nacional de Enfermedades Respiratorias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01417481 on ClinicalTrials.gov