Chronic Obstructive Pulmonary DiseasePhase 2NCT02877641
Cholecalciferol Supplementation in Strengthening Inspiratory Muscles in Cholecalciferol-Deficient Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Cholecalciferol, Laboratory Biomarker Analysis and Multivitamin in people with Chronic Obstructive Pulmonary Disease and Muscle Weakness, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Muscle Weakness
- What is being tested?
- Cholecalciferol, Laboratory Biomarker Analysis and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2014to 1 Feb 2017
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or ex-smoker with at least a 10-year pack history
- COPD, defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70% and FEV1% predicted < 80%
- 25-hydroxy vitamin D3 (25[OH]D3) level less than 20 ng/mL prior to study initiation
- Willingness to comply with study guidelines
- Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
- Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Personal history of lung cancer or head and neck cancer
- History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
- History of known thyroid disease
- History of known sarcoid disease
- History of known abnormalities in calcium metabolism
- Hypercalcemia (serum calcium in excess of laboratory upper limit normal [ULN])
Show all 17Show fewer
- Self-reported consumption of more than 4 alcoholic drinks per day
- Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
- History of known renal dysfunction
- History of known nephrolithiasis (kidney stones)
- Current use of supplemental oxygen
- Inability to exercise due to musculoskeletal issue, osteoarthritis or underlying cardiac disease
- Current participation in a cancer intervention prevention study, except for smoking cessation
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
- Inability to swallow pills
- Vitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment
- Positive Pregnancy Test
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients
This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient patients with COPD.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the effect of D vitamin (vitamin D3) supplementation on inspiratory muscle strength in vitamin D3-deficient chronic obstructive pulmonary disease (COPD) patients. (Roswell Park Cancer Institute [RPCI]/University at Buffalo [UB] study) II. To establish the 12 month conversion rate. (University of Pittsburgh Cancer Institute [UPCI] study)
SECONDARY OBJECTIVES:
- To establish the effect of vitamin D3 supplementation on peripheral muscle strength and exercise capacity in vitamin D3-deficient COPD patients. (RPCI/UB study) II. To establish the 3 and 6-month conversion rates. (UPCI study) III. To examine whether vitamin D3 supplementation is equally effective in COPD patients who are current versus former smokers. (UPCI study)
TERTIARY OBJECTIVES:
- To explore the effects of vitamin D3 supplementation in COPD patients on biomarkers of lung cancer risk, inflammation, and pulmonary function. (UPCI study)
OUTLINE: Patients are randomized to 1 of 2 arms.
CONTROL ARM: Patients receive a placebo and multivitamin orally (PO) once daily (QD) for 52 weeks.
SUPPLEMENTATION ARM: Patients receive a multivitamin and cholecalciferol supplement PO QD for 52 weeks.
After completion of study treatment, patients are followed up for 1 year.
- Being tested
- Cholecalciferol, Laboratory Biomarker Analysis, Multivitamin, Placebo, Questionnaire Administration
- Keywords
- Current Smoker, Former Smoker
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
MultivitaminDietary supplement
Also called Geritol, Vitamin Supplements (NOS)
Given PO
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Control arm (multivitamin, placebo) | Active comparator | Patients receive a placebo and multivitamin orally each day for 52 weeks. Receives: Other: Laboratory Biomarker Analysis; Dietary Supplement: Multivitamin; Other: Placebo; Other: Questionnaire Administration |
| Supplementation arm (multivitamin, cholecalciferol) | Experimental | Patients receive a multivitamin and cholecalciferol supplement orally each day for 52 weeks. Receives: Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis; Dietary Supplement: Multivitamin; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
75% will be considered a success.
Measured: At 12 months
Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study)
Will be analyzed using linear mixed model by regressing the repeated outcome on the group indicator (treatment or control) and other appropriate covariates. Appropriate within-subject covariance will be determined from an exploratory study. The effect of vitamin D3 supplementation will be tested using an approximate t-test.
Measured: Baseline to 24 weeks
Secondary outcomes (5)
Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study)
Peak oxygen consumption will be used to establish cardiovascular fitness. Breath-by-breath measurements of minute ventilation, tidal volume, breathing frequency, end tidal carbon dioxide, carbon dioxide production and oxygen consumption will be continuously measured.
Measured: Baseline to 24 weeks
Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study)
The elbow flexion test (upper extremity) requires participants to curl a standard 8 lb weight as many times as possible in a 30 second time period.
Measured: Baseline to 24 weeks
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Efficacy in in COPD patients who are current versus former smokers will be compared.
Measured: At 3 months
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Efficacy in in COPD patients who are current versus former smokers will be compared.
Measured: At 6 months
Change in peripheral muscle strength assessed by squat test (RPCI/UB study)
This functional sit-to-stand test measures lower extremity strength. Participants will perform as many sit-to-stand repetitions from a standard height chair in 60 seconds as possible.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start16 Apr 2014
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Martin Mahoney, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877641
- Sponsor's protocol ID
- I 240913
- Other IDs
- NCI-2016-00524, I 240913, P30CA016056, P50CA090440
- Status last verified
- Feb 2017
- First submitted
- 17 Aug 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients
- ClinicalTrials.gov ID
- NCT02877641
- Acronym / sponsor ID
- I 240913
- Keywords
- Current Smoker, Former Smoker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Apr 2014 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 24 Aug 2016 (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.
This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient patients with COPD.
Detailed description
PRIMARY OBJECTIVES:
- To establish the effect of D vitamin (vitamin D3) supplementation on inspiratory muscle strength in vitamin D3-deficient chronic obstructive pulmonary disease (COPD) patients. (Roswell Park Cancer Institute [RPCI]/University at Buffalo [UB] study) II. To establish the 12 month conversion rate. (University of Pittsburgh Cancer Institute [UPCI] study)
SECONDARY OBJECTIVES:
- To establish the effect of vitamin D3 supplementation on peripheral muscle strength and exercise capacity in vitamin D3-deficient COPD patients. (RPCI/UB study) II. To establish the 3 and 6-month conversion rates. (UPCI study) III. To examine whether vitamin D3 supplementation is equally effective in COPD patients who are current versus former smokers. (UPCI study)
TERTIARY OBJECTIVES:
- To explore the effects of vitamin D3 supplementation in COPD patients on biomarkers of lung cancer risk, inflammation, and pulmonary function. (UPCI study)
OUTLINE: Patients are randomized to 1 of 2 arms.
CONTROL ARM: Patients receive a placebo and multivitamin orally (PO) once daily (QD) for 52 weeks.
SUPPLEMENTATION ARM: Patients receive a multivitamin and cholecalciferol supplement PO QD for 52 weeks.
After completion of study treatment, patients are followed up for 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm (multivitamin, placebo) | Active comparator | Other: Laboratory Biomarker Analysis, Dietary Supplement: Multivitamin, Other: Placebo, Other: Questionnaire AdministrationPatients receive a placebo and multivitamin orally each day for 52 weeks. |
| Supplementation arm (multivitamin, cholecalciferol) | Experimental | Dietary Supplement: Cholecalciferol, Other: Laboratory Biomarker Analysis, Dietary Supplement: Multivitamin, Other: Questionnaire AdministrationPatients receive a multivitamin and cholecalciferol supplement orally each day for 52 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current or ex-smoker with at least a 10-year pack history
- COPD, defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70% and FEV1% predicted < 80%
- 25-hydroxy vitamin D3 (25[OH]D3) level less than 20 ng/mL prior to study initiation
- Willingness to comply with study guidelines
- Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
Key exclusion criteria (17 listed)
- Personal history of lung cancer or head and neck cancer
- History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
- History of known thyroid disease
- History of known sarcoid disease
- History of known abnormalities in calcium metabolism
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 |
|---|---|---|
| CholecalciferolAlso: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3Given PO | Dietary supplement | Supplementation arm (multivitamin, cholecalciferol) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Control arm (multivitamin, placebo), Supplementation arm (multivitamin, cholecalciferol) |
| MultivitaminAlso: Geritol, Vitamin Supplements (NOS)Given PO | Dietary supplement | Control arm (multivitamin, placebo), Supplementation arm (multivitamin, cholecalciferol) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Control arm (multivitamin, placebo) |
| Questionnaire AdministrationAncillary studies | Other | Control arm (multivitamin, placebo), Supplementation arm (multivitamin, cholecalciferol) |
Primary outcome
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Time frame: At 12 months
75% will be considered a success.
Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study)
Time frame: Baseline to 24 weeks
Will be analyzed using linear mixed model by regressing the repeated outcome on the group indicator (treatment or control) and other appropriate covariates. Appropriate within-subject covariance will be determined from an exploratory study. The effect of vitamin D3 supplementation will be tested using an approximate t-test.
5 secondary outcomes
Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study)
Time frame: Baseline to 24 weeks
Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study)
Time frame: Baseline to 24 weeks
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Time frame: At 3 months
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Time frame: At 6 months
Change in peripheral muscle strength assessed by squat test (RPCI/UB study)
Time frame: Baseline to 24 weeks
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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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 Mahoney principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol, Laboratory Biomarker Analysis and Multivitamin in people with Chronic Obstructive Pulmonary Disease and Muscle Weakness, run by Roswell Park Cancer Institute 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 15 Feb 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
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?
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study) (time frame: At 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2017.