Vitamin D Supplementation in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— PRECOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122627
• Other study ID #: 5.1.13.033
• Status: Completed
• Phase: N/A
• Start date: April 10, 2015
• Est. completion date: June 26, 2019

Study information

• Verified date: September 2019
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Vitamin D
Colecalciferol 16.800 IU per week
• Placebo

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (3)

Lead Sponsor	Collaborator
VU University Medical Center	Leiden University Medical Center, Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbation rate	Definition of an exacerbation is according to the Anthonisen criteria	1 year
Secondary	Time to first and second exacerbation	Time to first and second exacerbation	1 year
Secondary	Time to first hospitalisation	Time to first hospitalisation	1 year
Secondary	FEV1	Forced Expiratory Volume in 1 sec	1 year
Secondary	IC	Inspiratory capacity	1 year
Secondary	FEV1/FVC	Forced expiratory volume in 1 sec/ forced vital capacity	1 year
Secondary	FRC	Functional residual capacity	1 year
Secondary	RV	Residual volume	1 year
Secondary	TLC	Total lung capacity	1 year
Secondary	MIP	Maximal inspiratory pressure	1 year
Secondary	MEP	Maximal expiratory pressure	1 year
Secondary	SMWT	Six-minute walk test	1 year
Secondary	Chair stand test	Chair stand test	1 year
Secondary	3-meter walking test	3-meter walking test	1 year
Secondary	Tandem stand test	Tandem stand test	1 year
Secondary	Total score physical function tests	The sum score of the physical function tests	1 year
Secondary	Hand grip strength	Hand grip strength	1 year
Secondary	Quality of life (SGRQ)	QoL by the St George respiratory questionnaire	1 year
Secondary	Quality of life (SF12)	QoL by the 12 item short form survey	1 year
Secondary	Anxiety (HADS)	Anxiety by the hospital anxiety and depression scale	1 year
Secondary	Depression (CESD)	Depression by the center for epidemiologic studies depression scale	1 year
Secondary	Quality of life (CCQ)	QoL by the Clinical COPD Questionnaire score	1 year
Secondary	Concentrations of antimicrobial peptides and pro-inflammatory mediators in nasal secretions	AMPs in nasal secretions	1 year
Secondary	Ex-vivo cytokine production capacity of peripheral blood mononuclear cells and immunophenotyping	cytokine production capacity by PBMCs	1 year
Secondary	Typing of bacteria and viruses in nasal secretions	Typing of bacteria and viruses in nasal secretions	1 year
Secondary	Use of corticosteroids	Use of corticosteroids	1 year
Secondary	Use of antibiotics	Use of antibiotics	1 year
Secondary	Physical activity (SQUASH)	physical activity by short questionnaire to assess health-enhancing physical activity	1 year