Vitamin D Supplementation in Patients With COPD

• Status: Completed
• Trial end date: 2019-06-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborators: Leiden University Medical Center; Radboud University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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