NCT02122627

Vitamin D Supplementation in Patients With COPD

Prevention of Exacerbations in Patients With COPD Through Vitamin D Supplementation: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Vitamin D has an immunomodulatory role. the aim of the present study is to assess the effect of vitamin D supplementation on exacerbation rate of COPD patient with a vitamin D deficiency.

Detailed description

Rationale: Although vitamin D is well known for its function in calcium homeostasis and bone mineralisation, several studies have shown immunomodulatory effects of vitamin D. Vitamin D deficiency is a common problem in patients with COPD.. Objective: To assess the effect of vitamin D supplementation on exacerbation rate in patients with COPD and a vitamin D deficiency. Study design: Randomized, multi-center, double-blind, placebo-controlled intervention study. Study population: 240 patients aged 40 years and older with COPD and a vitamin D deficiency (25-hydroxyvitamin D concentration(25OHD)\<50 nmol/l) with a COPD exacerbation. An exacerbation is defined as sustained worsening of respiratory symptoms during 48 hours and requiring oral corticosteroid, antibiotic or combination treatment that was initiated by a physician. Respiratory symptoms include at least one of the Anthonisen criteria (increased dyspnoea, sputum volume or purulence). Patients with a severe vitamin D deficiency (25OHD\<15 nmol/l), known osteoporosis and/or use of vitamin D supplementation \> 400 IU per day will be excluded. Intervention: Participants will be randomly allocated to receive vitamin D3 16800 IU or placebo orally once a week during 1 year. Main study parameters/endpoints: The primary endpoint is exacerbation rate. Follow-up of the study: Recruitment of participants is more troublesome than expected due to several reasons, more use of vitamin D supplements, higher 250hydroxyvitamin D levels than anticipated, less suitability due to presence other exclusion criteria. 29/8/2017 total number recruited participants is 119 10/7/2018 closure of recruitment, total number recruited participants is 158

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Vitamin D	Colecalciferol 16.800 IU per week
DRUG	Placebo

Timeline

• Start date: 2015-04-10
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2014-04-24
• Last updated: 2019-09-10

Locations

2 sites across 1 country: Netherlands