Clinical trial NCT02043717: Increased Vitamin D Reduces Pulmonary Exacerbations in CF
Official title: Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Vitamin D
Lung function
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF patients (both children and adults) from The Center for Chronic Diseases in 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.

Eligibility 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)

Primary outcomes:
measure: FEV1 (by % of predicted)
timeFrame: Baseline, and then, on average, once a month during trial (at least one year).
Secondary outcomes:
measure: Pulmonary Exacerbations (PEs)
timeFrame: Average number in a year
measure: Days of Hospitalisation (DOHs)
timeFrame: Average number in a year
Other outcomes:
measure: Vitamin D level
timeFrame: Baseline, and then, on average, once a month during trial (at least one year).
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Wilschanski, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tangpricha V, Kelly A, Stephenson A, Maguiness K, Enders J, Robinson KA, Marshall BC, Borowitz D; Cystic Fibrosis Foundation Vitamin D Evidence-Based Review Committee. 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. J Clin Endocrinol Metab. 2012 Apr;97(4):1082-93. doi: 10.1210/jc.2011-3050. Epub 2012 Mar 7.
citation: Green D, Carson K, Leonard A, Davis JE, Rosenstein B, Zeitlin P, Mogayzel P Jr. Current treatment recommendations for correcting vitamin D deficiency in pediatric patients with cystic fibrosis are inadequate. J Pediatr. 2008 Oct;153(4):554-9. doi: 10.1016/j.jpeds.2008.04.058. Epub 2008 Jun 27.
citation: Abu-Fraiha Y, Elyashar-Earon H, Shoseyov D, Cohen-Cymberknoh M, Armoni S, Kerem E, Wilschanski M. Increasing Vitamin D Serum Levels Is Associated With Reduced Pulmonary Exacerbations in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):110-115. doi: 10.1097/MPG.0000000000002126.