Deficiency of Vitamin D3NCT02532062
The Pittsburgh Vitamin D Study: Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer
A study testing Cholecalciferol and multivitamin in people with Deficiency of Vitamin D3 and COPD, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study aims to establish the ability of 4,000 IU oral vitamin D3 per day (in combination with a daily multivitamin) to safely convert vitamin D3-deficient subjects at increased risk of lung cancer to a vitamin D3-sufficient state, and to explore effects of vitamin D3 supplementation in this population on markers… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Deficiency of Vitamin D3, COPD
- What is being tested?
- Cholecalciferol and multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 Jun 2018
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years old.
- Current or ex-smoker with at least 10 pack-year history
- COPD, GOLD II or greater (defined as FEV1/FVC <70% and FEV1 % predicted <80%)
- 25(OH)D3 level ≤25 ng/mL
- Willingness to comply with study guidelines.
- Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
- Participant 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 ULN)
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- 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 participation in another cancer chemoprevention study
- 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.
- Being pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Efficacy of Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer (The Pittsburgh Vitamin D Study)
This study aims to establish the ability of 4,000 IU oral vitamin D3 per day (in combination with a daily multivitamin) to safely convert vitamin D3-deficient subjects at increased risk of lung cancer to a vitamin D3-sufficient state, and to explore effects of vitamin D3 supplementation in this population on markers of inflammation and lung cancer risk. Current and former smokers with chronic obstructive pulmonary disease (COPD) are at increased risk of developing lung cancer and represent the clinical population of interest for this study.
Read the detailed description
Smoking avoidance or cessation are essential to the prevention of lung cancer. However, not all smokers are able to quit smoking and, importantly, former smokers remain at increased risk of lung cancer compared to never smokers. Despite smoking prevention/cessation programs and treatment advances, lung cancer is still the leading cause of cancer-related mortality in the United States with more than 158,000 individuals expected to die from this disease in 2015. Effective and safe prevention strategies are expected to be more successful in reducing lung cancer deaths than treatment of established disease.
NF-kappaB (NF-kB) pathway activation underlies smoking-related inflammation and lung carcinogenesis, and those agents which suppress NF-κB signaling may have the potential to prevent lung cancer. Recent preclinical data from our group and others indicate that the active metabolite of vitamin D3, 1,25-dihydroxyvitamin D3 [1,25(OH)2D3], has lung cancer chemopreventive activity. Because systemic 1,25(OH)2D3 administration is complicated by its hypercalcemia-inducing properties, the investigators propose to use oral supplementation with vitamin D3 (cholecalciferol) to safely achieve chemopreventive 1,25(OH)2D3 levels within the lung.
This randomized, placebo-controlled Phase IIb study aims to evaluate the ability of 4,000 IU oral vitamin D3/day (in combination with a daily multivitamin) to safely convert vitamin D3-deficient subjects at risk of lung cancer to a vitamin D3-sufficient state.
Study participants will be recruited from among Pittsburgh Lung Screening Study Extension (PLuSS-X) and PLuSS-XX participants not diagnosed with lung cancer, and from among the patient population seen by the PI of this protocol. The study consists of two stages, a screening and an intervention stage, with their own consent forms. In Stage 1 (the screening stage), the vitamin D3 status of subjects potentially eligible for participation in the intervention will be determined; in Stage 2 (the intervention stage), supplementation with oral vitamin D3 will be evaluated.
Participants who fulfill the eligibility criteria and provided signed consent for Stage 2 will be randomized in a 2:1 ratio to receive: (A) 4,000 IU vitamin D3 plus a multivitamin (containing 400 IU vitamin D3) daily for one year, or (B) a placebo vitamin D3 pill plus a multivitamin daily for one year. Both groups will contain equal numbers of current and ex-smokers; in total 120 subjects will be randomized. To evaluate whether supplementation safely corrects vitamin D3 deficiency in this population, blood samples will be obtained at baseline, 3, 6, and 12 months of intervention for evaluation of 25(OH)D3 and serum calcium. The collected blood will also be used to facilitate biomarker assessment. Pulmonary function tests (PFTs) will be obtained at baseline and repeated after 12 months to determine whether supplementation has an effect on lung function. Sputum and nasal epithelium will be collected at baseline, 6 months and 12 months to facilitate biomarker assessment.
- Study Objectives Primary Objective: To establish the 12-month conversion rate (i.e., proportion of subjects whose baseline vitamin D3 deficiency is corrected after 12 months of supplementation).
Secondary Objectives: To determine the 3-month and 6-month conversion rates and examine the effect of vitamin D3 supplementation in current and former smokers. Additionally, to examine the effects of vitamin D3 supplementation on biomarkers of lung cancer risk, inflammation, and pulmonary function.
- Conditions
- Deficiency of Vitamin D3, COPD
- Being tested
- Cholecalciferol, multivitamin, Placebo
- Keywords
- lung cancer risk, cigarette smokers
- 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.
CholecalciferolDietary supplement
Also called Vitamin D3
4,000 IU, oral, once a day for one year
multivitaminDietary supplement
oral, once a day for one year
PlaceboDietary supplement
oral, once a day for one year
| Study group | Role | What they receive |
|---|---|---|
| Supplementation | Experimental | Participants who are assigned to the Supplementation arm will receive a vitamin D supplement containing 4,000 units of vitamin D3 (cholecalciferol; capsule form) plus an oral multivitamin containing 400 units of vitamin D3 daily for a period of one year. Receives: Dietary Supplement: Cholecalciferol; Dietary Supplement: multivitamin |
| Placebo | Active comparator | Participants who are assigned to the Placebo arm will receive a placebo supplement plus an oral multivitamin containing 400 units of vitamin D3 daily for a period of one year. Receives: Dietary Supplement: multivitamin; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 12-month conversion rate
The proportion of subjects whose baseline vitamin D3 deficiency is corrected after 12 months of supplementation (i.e., the 12-month conversion rate).
Measured: 12 months
Secondary outcomes (6)
The 3-month conversion rate
Measured: 3 months
The 6-month conversion rate
Measured: 6 months
Pulmonary function as measured by spirometry
Effect of vitamin D supplementation on lung function as measured by spirometry will be evaluated.
Measured: 12 months
Promoter methylation status in sputum and nasal swab samples
Effect of supplementation on promoter methylation status of genes previously reported associated with lung cancer risk (e.g., RAMP2, p16, MGMT) in sputum and nasal swab samples will be explored.
Measured: 12 months
Protein expression in sputum and nasal swab samples
Effect of supplementation on the expression of proteins, including inflammation and vitamin D metabolism-related proteins, in sputum and nasal swab samples will be explored.
Measured: 12 months
Concentration of inflammatory markers in blood
Blood samples will be analyzed for inflammatory markers such as IL6 and CRP and the effect of supplementation on the examined cytokines will be explored.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startJan 2016
- Primary completion1 Jan 2018
- Study completion1 Jun 2018
Why it stopped: lost funding, limited eligibility due to pre-existing vitamin D supplementation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency of Vitamin D3Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David O. Wilson, University of Pittsburgh
- Investigators
- David Wilson, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532062
- Sponsor's protocol ID
- PRO15020031
- Other IDs
- P50CA090440
- Status last verified
- Jun 2018
- First submitted
- 11 Aug 2015
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer (The Pittsburgh Vitamin D Study)
- ClinicalTrials.gov ID
- NCT02532062
- Acronym / sponsor ID
- PRO15020031
- Conditions
- Deficiency of Vitamin D3, COPD
- Keywords
- lung cancer risk, cigarette smokers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lost funding, limited eligibility due to pre-existing vitamin D supplementation
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2016
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 25 Aug 2015 (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 study aims to establish the ability of 4,000 IU oral vitamin D3 per day (in combination with a daily multivitamin) to safely convert vitamin D3-deficient subjects at increased risk of lung cancer to a vitamin D3-sufficient state, and to explore effects of vitamin D3 supplementation in this population on markers of inflammation and lung cancer risk. Current and former smokers with chronic obstructive pulmonary disease (COPD) are at increased risk of developing lung cancer and represent the clinical population of interest for this study.
Detailed description
Smoking avoidance or cessation are essential to the prevention of lung cancer. However, not all smokers are able to quit smoking and, importantly, former smokers remain at increased risk of lung cancer compared to never smokers. Despite smoking prevention/cessation programs and treatment advances, lung cancer is still the leading cause of cancer-related mortality in the United States with more than 158,000 individuals expected to die from this disease in 2015. Effective and safe prevention strategies are expected to be more successful in reducing lung cancer deaths than treatment of established disease.
NF-kappaB (NF-kB) pathway activation underlies smoking-related inflammation and lung carcinogenesis, and those agents which suppress NF-κB signaling may have the potential to prevent lung cancer. Recent preclinical data from our group and others indicate that the active metabolite of vitamin D3, 1,25-dihydroxyvitamin D3 [1,25(OH)2D3], has lung cancer chemopreventive activity. Because systemic 1,25(OH)2D3 administration is complicated by its hypercalcemia-inducing properties, the investigators propose to use oral supplementation with vitamin D3 (cholecalciferol) to safely achieve chemopreventive 1,25(OH)2D3 levels within the lung.
This randomized, placebo-controlled Phase IIb study aims to evaluate the ability of 4,000 IU oral vitamin D3/day (in combination with a daily multivitamin) to safely convert vitamin D3-deficient subjects at risk of lung cancer to a vitamin D3-sufficient state.
Study participants will be recruited from among Pittsburgh Lung Screening Study Extension (PLuSS-X) and PLuSS-XX participants not diagnosed with lung cancer, and from among the patient population seen by the PI of this protocol. The study consists of two stages, a screening and an intervention stage, with their own consent forms. In Stage 1 (the screening stage), the vitamin D3 status of subjects potentially eligible for participation in the intervention will be determined; in Stage 2 (the intervention stage), supplementation with oral vitamin D3 will be evaluated.
Participants who fulfill the eligibility criteria and provided signed consent for Stage 2 will be randomized in a 2:1 ratio to receive: (A) 4,000 IU vitamin D3 plus a multivitamin (containing 400 IU vitamin D3) daily for one year, or (B) a placebo vitamin D3 pill plus a multivitamin daily for one year. Both groups will contain equal numbers of current and ex-smokers; in total 120 subjects will be randomized. To evaluate whether supplementation safely corrects vitamin D3 deficiency in this population, blood samples will be obtained at baseline, 3, 6, and 12 months of intervention for evaluation of 25(OH)D3 and serum calcium. The collected blood will also be used to facilitate biomarker assessment. Pulmonary function tests (PFTs) will be obtained at baseline and repeated after 12 months to determine whether supplementation has an effect on lung function. Sputum and nasal epithelium will be collected at baseline, 6 months and 12 months to facilitate biomarker assessment.
- Study Objectives Primary Objective: To establish the 12-month conversion rate (i.e., proportion of subjects whose baseline vitamin D3 deficiency is corrected after 12 months of supplementation).
Secondary Objectives: To determine the 3-month and 6-month conversion rates and examine the effect of vitamin D3 supplementation in current and former smokers. Additionally, to examine the effects of vitamin D3 supplementation on biomarkers of lung cancer risk, inflammation, and pulmonary function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Dietary Supplement: Cholecalciferol, Dietary Supplement: multivitaminParticipants who are assigned to the Supplementation arm will receive a vitamin D supplement containing 4,000 units of vitamin D3 (cholecalciferol; capsule form) plus an oral multivitamin containing 400 units of vitamin D3 daily for a period of one year. |
| Placebo | Active comparator | Dietary Supplement: multivitamin, Dietary Supplement: PlaceboParticipants who are assigned to the Placebo arm will receive a placebo supplement plus an oral multivitamin containing 400 units of vitamin D3 daily for a period of one year. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 50 years old.
- Current or ex-smoker with at least 10 pack-year history
- COPD, GOLD II or greater (defined as FEV1/FVC <70% and FEV1 % predicted <80%)
- 25(OH)D3 level ≤25 ng/mL
- Willingness to comply with study guidelines.
Key exclusion criteria (15 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: Vitamin D34,000 IU, oral, once a day for one year | Dietary supplement | Supplementation |
| multivitaminoral, once a day for one year | Dietary supplement | Placebo, Supplementation |
| Placebooral, once a day for one year | Dietary supplement | Placebo |
Primary outcome
The 12-month conversion rate
Time frame: 12 months
The proportion of subjects whose baseline vitamin D3 deficiency is corrected after 12 months of supplementation (i.e., the 12-month conversion rate).
6 secondary outcomes
The 3-month conversion rate
Time frame: 3 months
The 6-month conversion rate
Time frame: 6 months
Pulmonary function as measured by spirometry
Time frame: 12 months
Promoter methylation status in sputum and nasal swab samples
Time frame: 12 months
Protein expression in sputum and nasal swab samples
Time frame: 12 months
Concentration of inflammatory markers in blood
Time frame: 12 months
Results and safety
The study was stopped early (reason given: lost funding, limited eligibility due to pre-existing vitamin D supplementation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
David Wilson, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol and multivitamin in people with Deficiency of Vitamin D3 and COPD, run by University of Pittsburgh 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 7 inclusion and 15 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 26 Jun 2018. 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.
Are results available for this study?
The study was stopped early (reason given: lost funding, limited eligibility due to pre-existing vitamin D supplementation). 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?
The 12-month conversion rate (time frame: 12 months). 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 26 Jun 2018.