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Completed

NCT Number: NCT02043717

Increased Vitamin D Reduces Pulmonary Exacerbations in CF

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.

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Key information

Conditions

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

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic Fibrosis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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