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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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16 December 2017 |
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Main ID: |
NCT02043717 |
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Date of registration:
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12/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Increased Vitamin D Reduces Pulmonary Exacerbations in CF
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Scientific title:
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Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic Fibrosis |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02043717 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Michael Wilschanski, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Organization |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical and laboratory diagnosis of Cystic Fibrosis
- Complete medical and nutritional follow-up for at least one year before changing the
vitamin D dosage and follow up for at least one year afterwards.
Exclusion Criteria:
- Age under 4 years old (because of the inability to assess lung function in a reliable
fashion)
Age minimum:
4 Years
Age maximum:
N/A
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: Vitamin D
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Primary Outcome(s)
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FEV1 (by % of predicted)
[Time Frame: Baseline, and then, on average, once a month during trial (at least one year).]
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Secondary Outcome(s)
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Days of Hospitalisation (DOHs)
[Time Frame: Average number in a year]
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Pulmonary Exacerbations (PEs)
[Time Frame: Average number in a year]
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Secondary ID(s)
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vitaminD-HMO-CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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