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Background & Objective

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

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Background & Objective

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  1. High doses of vitamin d to reduce exacerbation in chronic obstructive pulmonary disease: a randomized trial An Lehouck, PhD; Chantal Mathieu, MD, PhD; Claudia Carremans, MS; FemkeBaeke, PhD; Jan Verhaegen, MD, PhD; Johan Van Eldere, MD, PhD; Brigitte Decallonne, MD, PhD; Roger Bouillon, MD, PhD; Marc Decramer, PhD; and WimJanssens, MD, PhD

  2. Background & Objective • COPD is defined as an abnormal inflammatory response of the airways that block airflow and make breathing difficult. • Vitamin D deficiency is present in 60-75% of patients with COPD.

  3. Background & Objective • Background: Low serum Vitamin D (25-hydroxyvitamin D, or 25-[OH]D) levels associated with lower FEV1 and increased airway inflammation. • Objective: To investigate whether high doses of Vitamin D supplementation could reduce occurrence of COPD exacerbations/flare-ups.

  4. Methods: Study design and participants • Single-center, double-blind, randomized, placebo-controlled trial in Belgium over 1.5 year period • 182 patients with moderate to severe COPD recruited

  5. Methods: Study design and participants • Inclusion Criteria: • Have COPD diagnosis • 50+ years of age • Current/former smokers • Had less than 80% predicted FEV1 • Exclusion Criteria: • Hx of hypercalcemia, sarcoidosis, or active cancer • Those being treated with Vitamin D supplements for newly diagnosed osteoporosis • Those on long-term antibiotics with anti-inflammatory functions

  6. Methods: Randomization and Masking • First, 1 group received low dose Vitamin D (400-880 IU/day) at baseline for osteoporosis; one group not receiving low dose Vitamin D • Then, participants randomly assigned to blocks of 20 in which they would either receive monthly oral dose of 100,000 IU Vitamin D or a placebo • (those on low dose Vitamin D at starting point were divided evenly among groups)

  7. Methods: Procedures • Patients screened during hospitalization for an exacerbation of COPD • Randomization occurred 5-6 weeks after screening • Baseline characteristics • BMI • Airflow obstruction • Shortness of breath • Exercise Capacity Index • CharlsonComorbidity Index

  8. Methods: Procedures • Primary endpoint: time to first exacerbation • Secondary endpoints: exacerbation rate, time to 1st hospitalization, time to 2nd exacerbation, FEV1, QOL, death

  9. Methods: Procedures • Follow-up visits every 4 months • Patients asked to keep diary every 2 weeks of: • Respiratory tract symptoms • Hospitalizations • Visits to healthcare providers • Changes in meds

  10. Methods: Statistical Analysis • Study designed to demonstrate at least 25% delay in time to 1st flare-up • 20% receiving low dose Vitamin D at baseline for osteoporosis • Of 182 participants, at least 120 needed who were not receiving any Vitamin D treatment at baseline • P values <0.05 statistically significant

  11. Results • 419 patients screened-> 340 eligible-> 182 included • 150 participants completed the study, 15 died, 17 dropped out • Overall, collected info on flare-ups for 175 participants, information on survival for all 182

  12. Results • Total of 468 exacerbations • 229 in Vitamin D group • 239 in placebo group

  13. Results • No significant difference in median time to 1st or 2nd exacerbation, exacerbations per year, or median time to hospitalization for flare-up • No significant difference in survival • 30 participants were Vitamin D deficient at baseline- 15 randomly chosen to receive Vitamin D supplement • Significant increase in serum 25-(OH)D levels

  14. Discussion • Main finding: monthly dose of 100,000 IU Vitamin D in addition to regular therapy does not reduce time to 1st exacerbation or amount of exacerbations in patients with moderate to severe COPD

  15. Discussion: Advantages • Study sample prone to exacerbations • Most participants chosen during hospitalization were admitted for acute exacerbation

  16. Discussion: Disadvantages • Small sample size • Most were already receiving treatment to control/decrease exacerbations • Difficult to obtain additional information on effect of Vitamin D alone

  17. Discussion • Lack of overall Vitamin D effect could be explained by local insensitivity due to smoking or chronic inflammation • Supports idea that Vitamin D deficiency in COPD patients could increase risk of flare-ups • More studies needed to explore need and safety for recommending higher doses of Vitamin D to see beneficial effects in areas other than bone health

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