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

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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

background objective
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.
background objective1
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.
methods study design and participants
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
methods study design and participants1
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
methods randomization and masking
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)
methods procedures
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
methods procedures1
Methods: Procedures
  • Primary endpoint: time to first exacerbation
  • Secondary endpoints: exacerbation rate, time to 1st hospitalization, time to 2nd exacerbation, FEV1, QOL, death
methods procedures2
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
methods statistical analysis
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
  • 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
  • Total of 468 exacerbations
    • 229 in Vitamin D group
    • 239 in placebo group
  • 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
  • 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
discussion advantages
Discussion: Advantages
  • Study sample prone to exacerbations
  • Most participants chosen during hospitalization were admitted for acute exacerbation
discussion disadvantages
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
  • 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