Vitamin D Supplementation in Patients With COPD

NCT ID: NCT02122627

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-10
• Study Completion Date: 2019-06-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vitamin D

colecalciferol 16.800 IU per week

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Colecalciferol 16.800 IU per week

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Vitamin D

Colecalciferol 16.800 IU per week

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Colecalciferol, cholecalciferol, vitamin D3

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Renate T de Jongh

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin den Heijer, Prof

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

Leiden University Medical Center

Leiden, , Netherlands

Radboud University Medical Center

Nijmegen, , Netherlands

Countries

Netherlands

References

Rafiq R, Aleva FE, Schrumpf JA, Heijdra YF, Taube C, Daniels JM, Lips P, Bet PM, Hiemstra PS, van der Ven AJ, den Heijer M, de Jongh RT. Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol. BMC Pulm Med. 2015 Sep 23;15:106. doi: 10.1186/s12890-015-0101-4.

Reference Type: BACKGROUND

PMID: 26399451 (View on PubMed)

Rafiq R, Aleva FE, Schrumpf JA, Daniels JM, Bet PM, Boersma WG, Bresser P, Spanbroek M, Lips P, van den Broek TJ, Keijser BJF, van der Ven AJAM, Hiemstra PS, den Heijer M, de Jongh RT; PRECOVID-study group. Vitamin D supplementation in chronic obstructive pulmonary disease patients with low serum vitamin D: a randomized controlled trial. Am J Clin Nutr. 2022 Aug 4;116(2):491-499. doi: 10.1093/ajcn/nqac083.

Reference Type: DERIVED

PMID: 35383823 (View on PubMed)

Other Identifiers

5.1.13.033

Identifier Type: -

Identifier Source: org_study_id