NCT02122627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

April 10, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

April 22, 2014

Last Update Submit

September 9, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Vitamin D, COPD, immunomodulation, pulmonary function

Outcome Measures

Primary Outcomes (1)

  • Exacerbation rate

    Definition of an exacerbation is according to the Anthonisen criteria

    1 year

Secondary Outcomes (27)

  • Time to first and second exacerbation

    1 year

  • Time to first hospitalisation

    1 year

  • FEV1

    1 year

  • IC

    1 year

  • FEV1/FVC

    1 year

  • +22 more secondary outcomes

Study Arms (2)

Vitamin D

EXPERIMENTAL

colecalciferol 16.800 IU per week

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Vitamin DDRUG

Colecalciferol 16.800 IU per week

Also known as: Colecalciferol, cholecalciferol, vitamin D3
Vitamin D
PlaceboDRUG
Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University Medical Center

Leiden, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 26399451BACKGROUND

  • 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.

    PMID: 35383823DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Martin den Heijer, Prof

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 24, 2014

Study Start

April 10, 2015

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

NL(2)