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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01417481 |
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Date of registration:
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15/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Glycine in Cystic Fibrosis
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Scientific title:
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Evaluation of the Capability of a Glycine Oral Supplement for Diminishing Bronchial Inflammation in Children With Cystic Fibrosis |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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13 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01417481 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Mario H Vargas, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Enfermedades Respiratorias |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
5 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Glycine
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Primary Outcome(s)
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Changes in Sputum Concentration of Inflammatory Biomarkers (G-CSF)
[Time Frame: 8 weeks]
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Changes in Sputum Concentration of Inflammatory Biomarkers (IL-6)
[Time Frame: 8 weeks]
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Changes in Sputum Concentration of Inflammatory Biomarkers (Other Than IL-6 and G-CSF)
[Time Frame: 8 weeks]
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Changes in Serum Concentration of Inflammatory Biomarkers (Other Than TNF-alpha)
[Time Frame: 8 weeks]
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Changes in Serum Concentration of Inflammatory Biomarkers (TNF-alpha)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Changes in Score for Sputum Production, Dyspnea and Global Symptoms
[Time Frame: 8 weeks]
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Changes in Other Spirometric Variables
[Time Frame: 8 weeks]
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Changes in FEV1, FEF25, and FEFmax
[Time Frame: 8 weeks]
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Changes in Pulse Oximetry, FEV1/FVC, and FEF50.
[Time Frame: 8 weeks]
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Changes in Clinical Data Scores (Other Than Sputum Production, Dyspnea and Global Symptoms)
[Time Frame: 8 weeks]
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Secondary ID(s)
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Glycine in CF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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