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Open Access 01-12-2015 | Study protocol

Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol

Authors: Rachida Rafiq, Floor E. Aleva, Jasmijn A. Schrumpf, Yvonne F. Heijdra, Christian Taube, Johannes MA Daniels, Paul Lips, Pierre M. Bet, Pieter S. Hiemstra, André JAM van der Ven, Martin den Heijer, Renate T. de Jongh

Published in: BMC Pulmonary Medicine | Issue 1/2015

Abstract

Background

Vitamin D is well known for its function in calcium homeostasis and bone mineralisation, but is increasingly studied for its potential immunomodulatory properties. Vitamin D deficiency is a common problem in patients with COPD. Previous studies have not demonstrated a beneficial effect of vitamin D on exacerbation rate in COPD patients. However, subgroup analyses suggested protective effects in vitamin D deficient patients. Our objective is to assess the effect of vitamin D supplementation on exacerbation rate specifically in vitamin D deficient COPD patients.

Methods/Design

We will perform a randomised, multi-center, double-blind, placebo-controlled intervention study. The study population consists of 240 COPD patients aged 40 years and older with vitamin D deficiency (25-hydroxyvitamin D concentration < 50 nmol/L). Participants will be recruited after an exacerbation and will be randomly allocated in a 1:1 ratio to receive vitamin D3 16800 IU or placebo orally once a week during 1 year. Participants will receive a diary card to register the incidence of exacerbations and changes in medication during the study period. Visits will be performed at baseline, at 6 months and at 12 months after randomisation. Participants will undergo spirometry, measurement of total lung capacity and assessment of maximal respiratory mouth pressure. Several physical performance and hand grip strength tests will be performed, questionnaires on quality of life and physical activity will be filled in, a nasal secretion sample and swab will be obtained and blood samples will be taken. The primary outcome will be exacerbation rate.

Discussion

This study will be the first RCT aimed at the effects of vitamin D supplementation on exacerbation rate in vitamin D deficient COPD patients. Also, in contrast to earlier studies that used infrequent dosing regimens, our trial will study effects of a weekly dose of vitamin D supplementation. Secondly, the immunomodulatory effects of vitamin D on host immune response of COPD patients and underlying mechanisms will be studied. Finally, the effects on physical functioning will be examined.

Trial registration

This trial is registered in ClinicalTrials.gov, ID number NCT02122627. Date of Registration April 2014.

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Title: Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol
Authors: Rachida Rafiq
Floor E. Aleva
Jasmijn A. Schrumpf
Yvonne F. Heijdra
Christian Taube
Johannes MA Daniels
Paul Lips
Pierre M. Bet
Pieter S. Hiemstra
André JAM van der Ven
Martin den Heijer
Renate T. de Jongh
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: BMC Pulmonary Medicine / Issue 1/2015
Electronic ISSN: 1471-2466
DOI: https://doi.org/10.1186/s12890-015-0101-4

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Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol

Abstract

Background

Methods/Design

Discussion

Trial registration

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Abstract

Background

Methods/Design

Discussion

Trial registration

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