- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00914810
Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients
June 7, 2013 updated by: Ken M. Kunisaki, Minneapolis Veterans Affairs Medical Center
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D
Cholecalciferol (2000 I.U.
daily)
|
2000 I.U. daily for 6 weeks
|
Placebo Comparator: Placebo
Placebo capsule (sugar pill daily)
|
Placebo (sugar pill) daily for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Time Frame: Baseline and 6 weeks
|
Baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ken M. Kunisaki, M.D., Minneapolis Veterans Affairs Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 4, 2009
First Submitted That Met QC Criteria
June 4, 2009
First Posted (Estimate)
June 5, 2009
Study Record Updates
Last Update Posted (Estimate)
June 11, 2013
Last Update Submitted That Met QC Criteria
June 7, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4129-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)
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University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (COPD).United Kingdom
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Reham Mohammed ElmorshedyCompletedChronic Obstructive Pulmonary Disease(COPD)Egypt
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AstraZenecaCompletedChronic Obstructive Pulmonary Disease (COPD).United Kingdom
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Virginia Commonwealth UniversityFisher and Paykel HealthcareCompletedChronic Obstructive Pulmonary Disease(COPD)United States
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Beaumont HospitalAerogenCompletedChronic Obstructive Pulmonary Disease | COPD | COPD Exacerbation | Copd Exacerbation AcuteIreland
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Medtronic BRCUnknownCOPD | COPD Exacerbation
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Chiesi Farmaceutici S.p.A.CompletedModerate to Severe Chronic Obstructive Pulmonary Disease (COPD)Bulgaria, Germany, Hungary, Poland, Russian Federation, United Kingdom
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Chiesi Farmaceutici S.p.A.CompletedChronic Obstructive Pulmonary Disease (COPD) | COPDUnited Kingdom
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Elpen Pharmaceutical Co. Inc.Completed
-
Aalborg UniversityCompletedChronic Obstructive Pulmonary Disease | COPD | COPD Exacerbation | COPD Exacerbation AcuteDenmark
Clinical Trials on Vitamin D (cholecalciferol)
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting
-
Johns Hopkins UniversityNational Institute on Aging (NIA)TerminatedVitamin D Deficiency | FallsUnited States
-
Sahlgrenska University Hospital, SwedenCompletedVitamin D Deficiency | Insulin Resistance | Chronic Kidney DiseaseSweden
-
McGill UniversityCompleted
-
Mansoura University Children HospitalCompletedPrematurity | Late-onset SepsisEgypt
-
Emory UniversityCompleted
-
Jorgen VestboWithdrawn
-
Bumi HermanCompleted
-
Wayne State UniversityNovartisUnknown
-
VA Office of Research and DevelopmentCompleted