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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

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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  • Authors+Show Affiliations

    ,

    Department of Internal Medicine and Endocrinology, VU University Medical Center, Amsterdam, The Netherlands. ra.rafiq@vumc.nl.

    ,

    Department of Pulmonology, Radboud University Medical Center, Nijmegen, The Netherlands. floor.aleva@radboudumc.nl. Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. floor.aleva@radboudumc.nl.

    ,

    Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands. j.a.schrumpf@lumc.nl.

    ,

    Department of Pulmonology, Radboud University Medical Center, Nijmegen, The Netherlands. yvonne.heijdra@radboudumc.nl.

    ,

    Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands. c.taube@lumc.nl.

    ,

    Department of Pulmonology, VU University Medical Center, Amsterdam, The Netherlands. j.daniels@vumc.nl.

    ,

    Department of Internal Medicine and Endocrinology, VU University Medical Center, Amsterdam, The Netherlands. p.lips@vumc.nl.

    ,

    Department of Clinical Pharmacology and Pharmacy, VU University Medical Center, Amsterdam, The Netherlands. pm.bet@vumc.nl.

    ,

    Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands. p.s.hiemstra@lumc.nl.

    ,

    Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. andre.vanderven@lumc.nl.

    ,

    Department of Internal Medicine and Endocrinology, VU University Medical Center, Amsterdam, The Netherlands. m.denheijer@vumc.nl.

    Department of Internal Medicine and Endocrinology, VU University Medical Center, Amsterdam, The Netherlands. rt.dejongh@vumc.nl.

    Source

    BMC pulmonary medicine 15: 2015 Sep 23 pg 106

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Cholecalciferol
    Dietary Supplements
    Double-Blind Method
    Female
    Hand Strength
    Humans
    Male
    Middle Aged
    Pulmonary Disease, Chronic Obstructive
    Quality of Life
    Respiratory Function Tests
    Surveys and Questionnaires
    Treatment Outcome
    Vitamin D
    Vitamin D Deficiency

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26399451

    Citation

    Rafiq, Rachida, et al. "Prevention of Exacerbations in Patients With COPD and Vitamin D Deficiency Through Vitamin D Supplementation (PRECOVID): a Study Protocol." BMC Pulmonary Medicine, vol. 15, 2015, p. 106.
    Rafiq R, Aleva FE, Schrumpf JA, et al. Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol. BMC Pulm Med. 2015;15:106.
    Rafiq, R., Aleva, F. E., Schrumpf, J. A., Heijdra, Y. F., Taube, C., Daniels, J. M., ... de Jongh, R. T. (2015). Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol. BMC Pulmonary Medicine, 15, p. 106. doi:10.1186/s12890-015-0101-4.
    Rafiq R, et al. Prevention of Exacerbations in Patients With COPD and Vitamin D Deficiency Through Vitamin D Supplementation (PRECOVID): a Study Protocol. BMC Pulm Med. 2015 Sep 23;15:106. PubMed PMID: 26399451.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol. AU - Rafiq,Rachida, AU - Aleva,Floor E, AU - Schrumpf,Jasmijn A, AU - Heijdra,Yvonne F, AU - Taube,Christian, AU - Daniels,Johannes Ma, AU - Lips,Paul, AU - Bet,Pierre M, AU - Hiemstra,Pieter S, AU - van der Ven,André Jam, AU - den Heijer,Martin, AU - de Jongh,Renate T, Y1 - 2015/09/23/ PY - 2015/05/07/received PY - 2015/09/11/accepted PY - 2015/9/25/entrez PY - 2015/9/25/pubmed PY - 2016/4/16/medline SP - 106 EP - 106 JF - BMC pulmonary medicine JO - BMC Pulm Med VL - 15 N2 - 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. SN - 1471-2466 UR - https://www.unboundmedicine.com/medline/citation/26399451/Prevention_of_exacerbations_in_patients_with_COPD_and_vitamin_D_deficiency_through_vitamin_D_supplementation__PRECOVID_:_a_study_protocol_ L2 - https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-015-0101-4 DB - PRIME DP - Unbound Medicine ER -