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Increased Vitamin D Reduces Pulmonary Exacerbations in CF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02043717
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : June 27, 2017
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:
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.

Condition or disease Intervention/treatment
Cystic Fibrosis Dietary Supplement: Vitamin D

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
CF patients
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:

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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.

  2. 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.

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CF patients (both children and adults) from The Center for Chronic Diseases in Hadassah Medical Organization.

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02043717

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Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Michael Wilschanski, Prof. Hadassah Medical Organization
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hadassah Medical Organization Identifier: NCT02043717    
Other Study ID Numbers: vitaminD-HMO-CTIL
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadassah Medical Organization:
Cystic Fibrosis
Vitamin D
Lung function
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents