Chronic Obstructive Pulmonary DiseasePRECOVIDNCT02122627
Vitamin D Supplementation in Patients With COPD
A study testing Vitamin D in people with Chronic Obstructive Pulmonary Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 2 sitesNetherlands
- Study dates
- 10 Apr 2015to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden
Radboud University Medical Center
Nijmegen
About this study
Official title: Prevention of Exacerbations in Patients With COPD Through Vitamin D Supplementation: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, COPD, immunomodulation, pulmonary function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Colecalciferol, cholecalciferol, vitamin D3
Colecalciferol 16.800 IU per week
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | colecalciferol 16.800 IU per week Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation rate
Definition of an exacerbation is according to the Anthonisen criteria
Measured: 1 year
Secondary outcomes (27)
Time to first and second exacerbation
Time to first and second exacerbation
Measured: 1 year
Time to first hospitalisation
Time to first hospitalisation
Measured: 1 year
FEV1
Forced Expiratory Volume in 1 sec
Measured: 1 year
IC
Inspiratory capacity
Measured: 1 year
FEV1/FVC
Forced expiratory volume in 1 sec/ forced vital capacity
Measured: 1 year
FRC
Functional residual capacity
Measured: 1 year
RV
Residual volume
Measured: 1 year
TLC
Total lung capacity
Measured: 1 year
MIP
Maximal inspiratory pressure
Measured: 1 year
MEP
Maximal expiratory pressure
Measured: 1 year
SMWT
Six-minute walk test
Measured: 1 year
Chair stand test
Chair stand test
Measured: 1 year
3-meter walking test
3-meter walking test
Measured: 1 year
Tandem stand test
Tandem stand test
Measured: 1 year
Total score physical function tests
The sum score of the physical function tests
Measured: 1 year
Hand grip strength
Hand grip strength
Measured: 1 year
Quality of life (SGRQ)
QoL by the St George respiratory questionnaire
Measured: 1 year
Quality of life (SF12)
QoL by the 12 item short form survey
Measured: 1 year
Anxiety (HADS)
Anxiety by the hospital anxiety and depression scale
Measured: 1 year
Depression (CESD)
Depression by the center for epidemiologic studies depression scale
Measured: 1 year
Quality of life (CCQ)
QoL by the Clinical COPD Questionnaire score
Measured: 1 year
Concentrations of antimicrobial peptides and pro-inflammatory mediators in nasal secretions
AMPs in nasal secretions
Measured: 1 year
Ex-vivo cytokine production capacity of peripheral blood mononuclear cells and immunophenotyping
cytokine production capacity by PBMCs
Measured: 1 year
Typing of bacteria and viruses in nasal secretions
Typing of bacteria and viruses in nasal secretions
Measured: 1 year
Use of corticosteroids
Use of corticosteroids
Measured: 1 year
Use of antibiotics
Use of antibiotics
Measured: 1 year
Physical activity (SQUASH)
physical activity by short questionnaire to assess health-enhancing physical activity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study start10 Apr 2015
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renate T de Jongh, Amsterdam UMC, location VUmc
- Investigators
- Martin den Heijer, Prof, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122627
- Sponsor's protocol ID
- 5.1.13.033
- Acronym
- PRECOVID
- Status last verified
- Sep 2019
- First submitted
- 22 Apr 2014
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26399451Rafiq 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.
PubMed 35383823
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Exacerbations in Patients With COPD Through Vitamin D Supplementation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02122627
- Acronym / sponsor ID
- PRECOVID / 5.1.13.033
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Vitamin D, COPD, immunomodulation, pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Radboud University Medical Center
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin Dcolecalciferol 16.800 IU per week |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Colecalciferol, cholecalciferol, vitamin D3Colecalciferol 16.800 IU per week | Drug | Vitamin D |
| Placebo | Drug | Placebo |
Primary outcome
Exacerbation rate
Time frame: 1 year
Definition of an exacerbation is according to the Anthonisen criteria
27 secondary outcomes
Time to first and second exacerbation
Time frame: 1 year
Time to first hospitalisation
Time frame: 1 year
FEV1
Time frame: 1 year
IC
Time frame: 1 year
FEV1/FVC
Time frame: 1 year
FRC
Time frame: 1 year
RV
Time frame: 1 year
TLC
Time frame: 1 year
MIP
Time frame: 1 year
MEP
Time frame: 1 year
SMWT
Time frame: 1 year
Chair stand test
Time frame: 1 year
3-meter walking test
Time frame: 1 year
Tandem stand test
Time frame: 1 year
Total score physical function tests
Time frame: 1 year
Hand grip strength
Time frame: 1 year
Quality of life (SGRQ)
Time frame: 1 year
Quality of life (SF12)
Time frame: 1 year
Anxiety (HADS)
Time frame: 1 year
Depression (CESD)
Time frame: 1 year
Quality of life (CCQ)
Time frame: 1 year
Concentrations of antimicrobial peptides and pro-inflammatory mediators in nasal secretions
Time frame: 1 year
Ex-vivo cytokine production capacity of peripheral blood mononuclear cells and immunophenotyping
Time frame: 1 year
Typing of bacteria and viruses in nasal secretions
Time frame: 1 year
Use of corticosteroids
Time frame: 1 year
Use of antibiotics
Time frame: 1 year
Physical activity (SQUASH)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Background: PubMed 26399451Rafiq 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.
- Derived from this study: PubMed 35383823Rafiq 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin den Heijer, Prof principal investigator
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Chronic Obstructive Pulmonary Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122627, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.