Increased Vitamin D Reduces Pulmonary Exacerbations in CF

NCT02043717 | Completed DMC

• 1 other identifier: vitaminD-HMO-CTIL
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Vitamin D; Lung function

Outcome Measures

Primary Outcomes (1)

• FEV1 (by % of predicted)

  Forced expiratory volume in the 1st second (by spirometry)

  Baseline, and then, on average, once a month during trial (at least one year).

Secondary Outcomes (2)

• Pulmonary Exacerbations (PEs)

  Average number in a year

• Days of Hospitalisation (DOHs)

  Average number in a year

Other Outcomes (1)

• Vitamin D level

  Baseline, and then, on average, once a month during trial (at least one year).

Study Arms (1)

CF patients

Both children and adults, with or without vitamin D deficiency.

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

CF patients

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CF patients (both children and adults) from The Center for Chronic Diseases in Hadassah Medical Organization.

You may qualify if:

• 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.

You may not qualify if:

• Age under 4 years old (because of the inability to assess lung function in a reliable fashion)

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (3)

• 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.

  PMID: 22399505 BACKGROUND

• 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.

  PMID: 18589445 BACKGROUND

• 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.

  PMID: 30095576 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michael Wilschanski, Prof.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)