Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00914810

Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 3 study testing Vitamin D (cholecalciferol) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Vitamin D (cholecalciferol)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Oct 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

COPD
Forced expiratory volume in one second (FEV1) < or = 50% of predicted
Smoking history of at least 10 pack-years
Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker)

Who cannot join

Currently taking > 500 I.U. per day of vitamin D supplements
Primary diagnosis of asthma
Uncompensated heart failure
Heart attack in the previous 6 months
Kidney disease (glomerular filtration rate < 45 mL/min/1.73m2)

Trial locations and contacts

1 site in 1 country.

United States1 site

Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417

Other trials in United States

About this study

Official title: Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.

The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Vitamin D (cholecalciferol), Placebo
Keywords: Chronic obstructive pulmonary disease, Vitamin D, Cholecalciferol, Skeletal muscle
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 D (cholecalciferol)Dietary supplement
2000 I.U. daily for 6 weeks
PlaceboDietary supplement
Placebo (sugar pill) daily for 6 weeks

Study groups in NCT00914810
Study group	Role	What they receive
Vitamin D	Experimental	Cholecalciferol (2000 I.U. daily) Receives: Dietary Supplement: Vitamin D (cholecalciferol)
Placebo	Placebo comparator	Placebo capsule (sugar pill daily) Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Short Physical Performance Battery (SPPB) Score
SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.
Measured: Baseline and 6 weeks

Secondary outcomes (1)

Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Oct 2011

First posted5 Jun 2009 (estimated)
Study startJun 2009
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00914810
Sponsor's protocol ID: 4129-A
Status last verified: Jun 2013
First submitted: 4 Jun 2009
Last updated: 11 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.
ClinicalTrials.gov ID: NCT00914810
Acronym / sponsor ID: 4129-A
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease, Vitamin D, Cholecalciferol, Skeletal muscle
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Minneapolis Veterans Affairs Medical CenterUS federal agency
Study start: Jun 2009
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 5 Jun 2009 (estimated)
Results: Posted 11 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vitamin D	Experimental	Dietary Supplement: Vitamin D (cholecalciferol)Cholecalciferol (2000 I.U. daily)
Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo capsule (sugar pill daily)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

COPD
Forced expiratory volume in one second (FEV1) < or = 50% of predicted
Smoking history of at least 10 pack-years
Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker)

Key exclusion criteria (5 listed)

Currently taking > 500 I.U. per day of vitamin D supplements
Primary diagnosis of asthma
Uncompensated heart failure
Heart attack in the previous 6 months
Kidney disease (glomerular filtration rate < 45 mL/min/1.73m2)

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 D (cholecalciferol)2000 I.U. daily for 6 weeks	Dietary supplement	Vitamin D
PlaceboPlacebo (sugar pill) daily for 6 weeks	Dietary supplement	Placebo

Primary outcome

Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline and 6 weeks
SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.

1 secondary outcome

Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Time frame: Baseline and 6 weeks

Results and safety

Results posted to the registry on 11 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	20	18
Vitamin D	19	18

Primary outcome: Change in Short Physical Performance Battery (SPPB) Score

Time frame: Baseline and 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 18	Vitamin D n = 18
Value	0.6 (1.7)	0.9 (1.6)

Placebo vs Vitamin D: Mean Difference (Net): 0.3 (95% CI -0.8 to 1.5), p = 0.55, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 20 (0%)	0 of 20 (0%)	Not reported
Vitamin D	0 of 19 (0%)	0 of 19 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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.

Ken M. Kunisaki, M.D. principal investigator

Minneapolis Veterans Affairs Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D (cholecalciferol) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.

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 4 inclusion and 5 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 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Short Physical Performance Battery (SPPB) Score (time frame: Baseline and 6 weeks). 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 NCT00914810.

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 11 Jun 2013.