Increased Vitamin D Reduces Pulmonary Exacerbations in CF

Study Overview
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Brief Summary
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The investigators study is designed to test the hypothesis that correction of vitamin D in CF patients can increase their lung function and decrease the number of their pulmonary exacerbations.

Detailed Description
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Vitamin D deficiency is a known problem in CF patients. The CF Foundation Committee published in April 2012 new guidelines for administering vitamin D in CF patients. The investigators' study is designed to look for association between normal serum vitamin D levels and lung function.  100 CF patients from The Center of Chronic Diseases in Hadassah Medical Organization will be treated according to the new guidelines, and their lung function will be tested once a month during the trial, which will be held for at least one year. In this study, the investigators' goal is to test the efficiency of the new guidelines in correcting serum vitamin D levels, and to follow other related factors such as growth indices (height, weight, BMI), bone mineral density, number of pulmonary exacerbations and number of hospital admissions.

Official Title
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Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility 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)

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CF patients<br>Both children and adults, with or without vitamin D deficiency. | Dietary Supplement: Vitamin D<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 (by % of predicted) | Forced expiratory volume in the 1st second (by spirometry) | Baseline, and then, on average, once a month during trial (at least one year). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Exacerbations (PEs) | 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. | Average number in a year | 
| Days of Hospitalisation (DOHs) | 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. | Average number in a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Vitamin D, Lung function