The Effect of Vitamin D on Lung Function in Patients With Cystic Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Hadassah Medical Organization Identifier:
First received: January 12, 2014
Last updated: January 21, 2014
Last verified: January 2014
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 Intervention
Cystic Fibrosis
Dietary Supplement: Vitamin D

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Effect of Vitamin D on Lung Function in Patients With Cystic Fibrosis

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • FEV1 (by % of predicted) [ Time Frame: Baseline, and then, on average, once a month during trial (at least one year). ]

Secondary Outcome Measures:
  • pulmonary exacerbations [ Time Frame: number in a year ]
  • Hospital admissions [ Time Frame: number in a year ]

Other Outcome Measures:
  • Vitamin D level [ Time Frame: Baseline, and then, on average, once a month during trial (at least one year). ]
    To assess correction efficiency and hypervitaminosis D

Biospecimen Retention:   Samples Without DNA

Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CF patients
Both children and adults, with or without vitamin D deficiency.
Dietary Supplement: Vitamin D

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:

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.

Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
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

Exclusion Criteria:

  • Age under 4 years old (because of the inability to assess lung function in a reliable fashion)
  Contacts and Locations
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Please refer to this study by its identifier: NCT02043717

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

Responsible Party: Hadassah Medical Organization Identifier: NCT02043717     History of Changes
Other Study ID Numbers: vitaminD-HMO-CTIL 
Study First Received: January 12, 2014
Last Updated: January 21, 2014

Keywords provided by Hadassah Medical Organization:
Cystic Fibrosis
Vitamin D
Lung function

Additional relevant MeSH terms:
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 processed this record on January 24, 2017