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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT02043717
First received: January 12, 2014
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pulmonary exacerbations [ Time Frame: number in a year ] [ Designated as safety issue: No ]
  • Hospital admissions [ Time Frame: number in a year ] [ Designated as safety issue: No ]

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


Biospecimen Retention:   Samples Without DNA

plasma


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: http://www.ncbi.nlm.nih.gov/pubmed/22399505


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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043717

Contacts
Contact: Michael Wilschanski, Prof. 00 9722-5845039 michaelwil@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Michael Wilschanski, Prof.    00 9722-5845039    michaelwil@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Michael Wilschanski, Prof.         
Sub-Investigator: Yasmeen Abu-Fraiha, B.Med.Sci         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael Wilschanski, Prof. Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02043717     History of Changes
Other Study ID Numbers: vitaminD-HMO-CTIL
Study First Received: January 12, 2014
Last Updated: January 21, 2014
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 21, 2014