Increased Vitamin D Reduces Pulmonary Exacerbations in CF
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|ClinicalTrials.gov Identifier: NCT02043717|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment|
|Cystic Fibrosis||Dietary Supplement: Vitamin D|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||90 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic Fibrosis|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||June 2015|
U.S. FDA Resources
Both children and adults, with or without vitamin D deficiency.
Dietary Supplement: Vitamin D
Supplementing oral cholecalciferol according to the new guidelines by:
Tangpricha V, Kelly a, Stephenson a, Maguiness K, Enders J, Robinson K a, et al. An update on the screening, diagnosis, management, and treatment of vitamin D deficiency in individuals with cystic fibrosis: evidence-based recommendations from the Cystic Fibrosis Foundation. The Journal of clinical endocrinology and metabolism [Internet]. 2012 May [cited 2012 Oct 31];97(4):1082-93. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22399505
- FEV1 (by % of predicted) [ Time Frame: Baseline, and then, on average, once a month during trial (at least one year). ]Forced expiratory volume in the 1st second (by spirometry)
- Pulmonary Exacerbations (PEs) [ Time Frame: Average number in a year ]Defined according to the research definition of the EuroCare CF Working Group - the need for additional antibiotic treatment as indicated by a recent change in at least two of the following: change in sputum volume, color or consistency, increased cough, increased malaise, fatigue or lethargy, increased dyspnea, anorexia or weight loss, decrease in FEV1 by ≥10% and/or presence of radiographic changes.
- Days of Hospitalisation (DOHs) [ Time Frame: Average number in a year ]Defined as days of admission to the hospital due to a CF-related complication such as pulmonary exacerbation, intravenous (IV) antibiotic treatment, pancreatitis, distal intestinal obstruction syndrome (DIOS), constipation and gastrointestinal bleeding or IV antibiotic treatment at home or as an outpatient at the CF Center.
- Vitamin D level [ Time Frame: Baseline, and then, on average, once a month during trial (at least one year). ]Serum levels for 25(OH)D
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043717
|Hadassah Medical Organization|
|Principal Investigator:||Michael Wilschanski, Prof.||Hadassah Medical Organization|