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Increased Vitamin D Reduces Pulmonary Exacerbations in CF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT02043717
First received: January 12, 2014
Last updated: June 25, 2017
Last verified: June 2017
  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: Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations 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). ]
    Forced expiratory volume in the 1st second (by spirometry)


Secondary Outcome Measures:
  • 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.

  • 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:
  • 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
plasma

Enrollment: 90
Actual Study Start Date: January 2014
Study Completion Date: June 2015
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

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


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   (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.
Criteria

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)
  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

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
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: June 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 19, 2017