Prevention of Exacerbations in Patients With COPD Through Vitamin D Supplementation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Exacerbation rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •aged above 40 years
- •GOLD stages II-IV and diagnosis COPD confirmed by a medical doctor.
- •minimum of 10 packyears of smoking
- •vitamin D deficiency (a serum 25-hydroxyvitamin D lower than 50 nmol/l)
- •ability to comply with all study requirements
排除标准
- •pregnant or lactating women, or subjects who intend to become pregnant within the study period
- •self-reported history of hypercalciemia or nephrolithiasis
- •self-reported presence of sarcoidosis
- •severe vitamin D deficiency (serum 25-hydroxyvitamin D lower than 15 nmol/l)
- •life expectation of less than 6 months on the basis of concurrent disease
- •interfering malignant diseases.
- •diagnosed osteoporosis
- •diagnosed asthma
- •diagnosed chronic kidney disease stage 4 or higher (estimated glomerular filtration rate ≤ 29 ml/min/1,73 m2)
- •serious mental impairment i.e. preventing to understand the study protocol or comply with the study aim; potentially unreliable patients and those judged by the investigator to be unsuitable for the study
- •use of maintenance dose oral corticosteroids
- •use of multivitamin supplement or vitamin D supplement which contains more than 400 IU per day
- •current participation in a clinical rehabilitation programme
研究组 & 干预措施
Vitamin D
colecalciferol 16.800 IU per week
干预措施: Vitamin D (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Exacerbation rate
时间窗: 1 year
Definition of an exacerbation is according to the Anthonisen criteria
次要结局
- IC(1 year)
- FRC(1 year)
- RV(1 year)
- TLC(1 year)
- MIP(1 year)
- MEP(1 year)
- FEV1(1 year)
- Time to first and second exacerbation(1 year)
- Time to first hospitalisation(1 year)
- Chair stand test(1 year)
- 3-meter walking test(1 year)
- Tandem stand test(1 year)
- Quality of life (SGRQ)(1 year)
- Quality of life (SF12)(1 year)
- Anxiety (HADS)(1 year)
- FEV1/FVC(1 year)
- SMWT(1 year)
- Total score physical function tests(1 year)
- Hand grip strength(1 year)
- Depression (CESD)(1 year)
- Quality of life (CCQ)(1 year)
- Concentrations of antimicrobial peptides and pro-inflammatory mediators in nasal secretions(1 year)
- Ex-vivo cytokine production capacity of peripheral blood mononuclear cells and immunophenotyping(1 year)
- Typing of bacteria and viruses in nasal secretions(1 year)
- Use of corticosteroids(1 year)
- Use of antibiotics(1 year)
- Physical activity (SQUASH)(1 year)
研究者
Renate T de Jongh
MD, PhD
Amsterdam UMC, location VUmc