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High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial.

Abstract

BACKGROUND

Low serum 25-hydroxyvitamin D (25-[OH]D) levels have been associated with lower FEV(1), impaired immunologic control, and increased airway inflammation. Because many patients with chronic obstructive pulmonary disease (COPD) have vitamin D deficiency, effects of vitamin D supplementation may extend beyond preventing osteoporosis.

OBJECTIVE

To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations.

DESIGN

Randomized, single-center, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00666367)

SETTING

University Hospitals Leuven, Leuven, Belgium.

PATIENTS

182 patients with moderate to very severe COPD and a history of recent exacerbations.

INTERVENTION

100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year.

MEASUREMENTS

The primary outcome was time to first exacerbation. Secondary outcomes were exacerbation rate, time to first hospitalization, time to second exacerbation, FEV(1), quality of life, and death.

RESULTS

Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group (mean between-group difference, 30 ng/mL [95% CI, 27 to 33 ng/mL]; P < 0.001). The median time to first exacerbation did not significantly differ between the groups (hazard ratio, 1.1 [CI, 0.82 to 1.56]; P = 0.41), nor did exacerbation rates, FEV(1), hospitalization, quality of life, and death. However, a post hoc analysis in 30 participants with severe vitamin D deficiency (serum 25-[OH]D levels <10 ng/mL) at baseline showed a significant reduction in exacerbations in the vitamin D group (rate ratio, 0.57 [CI, 0.33 to 0.98]; P = 0.042).

LIMITATION

This was a single-center study with a small sample size.

CONCLUSION

High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations. In participants with severe vitamin D deficiency at baseline, supplementation may reduce exacerbations.

PRIMARY FUNDING SOURCE

Applied Biomedical Research Program, Agency for Innovation by Science and Technology (IWT-TBM).

Links

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  • Authors+Show Affiliations

    ,

    University Hospitals Leuven, Belgium.

    , , , , , , , ,

    Source

    Annals of internal medicine 156:2 2012 Jan 17 pg 105-14

    MeSH

    Aged
    Antimicrobial Cationic Peptides
    Cause of Death
    Dietary Supplements
    Double-Blind Method
    Female
    Forced Expiratory Volume
    Humans
    Male
    Middle Aged
    Osteoporosis
    Phagocytosis
    Pulmonary Disease, Chronic Obstructive
    Quality of Life
    Recurrence
    Sputum
    Treatment Outcome
    Vitamin D

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    22250141

    Citation

    Lehouck, An, et al. "High Doses of Vitamin D to Reduce Exacerbations in Chronic Obstructive Pulmonary Disease: a Randomized Trial." Annals of Internal Medicine, vol. 156, no. 2, 2012, pp. 105-14.
    Lehouck A, Mathieu C, Carremans C, et al. High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2012;156(2):105-14.
    Lehouck, A., Mathieu, C., Carremans, C., Baeke, F., Verhaegen, J., Van Eldere, J., ... Janssens, W. (2012). High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial. Annals of Internal Medicine, 156(2), pp. 105-14. doi:10.7326/0003-4819-156-2-201201170-00004.
    Lehouck A, et al. High Doses of Vitamin D to Reduce Exacerbations in Chronic Obstructive Pulmonary Disease: a Randomized Trial. Ann Intern Med. 2012 Jan 17;156(2):105-14. PubMed PMID: 22250141.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial. AU - Lehouck,An, AU - Mathieu,Chantal, AU - Carremans,Claudia, AU - Baeke,Femke, AU - Verhaegen,Jan, AU - Van Eldere,Johan, AU - Decallonne,Brigitte, AU - Bouillon,Roger, AU - Decramer,Marc, AU - Janssens,Wim, PY - 2012/1/18/entrez PY - 2012/1/18/pubmed PY - 2012/7/4/medline SP - 105 EP - 14 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 156 IS - 2 N2 - BACKGROUND: Low serum 25-hydroxyvitamin D (25-[OH]D) levels have been associated with lower FEV(1), impaired immunologic control, and increased airway inflammation. Because many patients with chronic obstructive pulmonary disease (COPD) have vitamin D deficiency, effects of vitamin D supplementation may extend beyond preventing osteoporosis. OBJECTIVE: To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations. DESIGN: Randomized, single-center, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00666367) SETTING: University Hospitals Leuven, Leuven, Belgium. PATIENTS: 182 patients with moderate to very severe COPD and a history of recent exacerbations. INTERVENTION: 100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year. MEASUREMENTS: The primary outcome was time to first exacerbation. Secondary outcomes were exacerbation rate, time to first hospitalization, time to second exacerbation, FEV(1), quality of life, and death. RESULTS: Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group (mean between-group difference, 30 ng/mL [95% CI, 27 to 33 ng/mL]; P < 0.001). The median time to first exacerbation did not significantly differ between the groups (hazard ratio, 1.1 [CI, 0.82 to 1.56]; P = 0.41), nor did exacerbation rates, FEV(1), hospitalization, quality of life, and death. However, a post hoc analysis in 30 participants with severe vitamin D deficiency (serum 25-[OH]D levels <10 ng/mL) at baseline showed a significant reduction in exacerbations in the vitamin D group (rate ratio, 0.57 [CI, 0.33 to 0.98]; P = 0.042). LIMITATION: This was a single-center study with a small sample size. CONCLUSION: High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations. In participants with severe vitamin D deficiency at baseline, supplementation may reduce exacerbations. PRIMARY FUNDING SOURCE: Applied Biomedical Research Program, Agency for Innovation by Science and Technology (IWT-TBM). SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/22250141/High_doses_of_vitamin_D_to_reduce_exacerbations_in_chronic_obstructive_pulmonary_disease:_a_randomized_trial_ L2 - https://www.annals.org/article.aspx?doi=10.7326/0003-4819-156-2-201201170-00004 DB - PRIME DP - Unbound Medicine ER -