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

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Background objective

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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • 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


Results
Results obstructive pulmonary disease: a randomized trial

  • 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


Results1
Results obstructive pulmonary disease: a randomized trial

  • Total of 468 exacerbations

    • 229 in Vitamin D group

    • 239 in placebo group


Results2
Results obstructive pulmonary disease: a randomized trial

  • 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


Discussion
Discussion obstructive pulmonary disease: a randomized trial

  • 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 obstructive pulmonary disease: a randomized trial

  • Study sample prone to exacerbations

  • Most participants chosen during hospitalization were admitted for acute exacerbation


Discussion disadvantages
Discussion: Disadvantages obstructive pulmonary disease: a randomized trial

  • Small sample size

  • Most were already receiving treatment to control/decrease exacerbations

    • Difficult to obtain additional information on effect of Vitamin D alone


Discussion1
Discussion obstructive pulmonary disease: a randomized trial

  • 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