Increased Vitamin D Reduces Pulmonary Exacerbations in CF

Completed

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT02043717
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-12
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2015-01
• Study Completion: 2015-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-25
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CF patients	Vitamin D	Both children and adults, with or without vitamin D deficiency.

Primary Outcome Measures

Name	Time	Method
FEV1 (by % of predicted)	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

Name	Time	Method
Pulmonary Exacerbations (PEs)	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)	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.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel