Clinical trial · Interventional
The Pittsburgh Vitamin D Study: Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer
Efficacy of Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer (The Pittsburgh Vitamin D Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lost funding, limited eligibility due to pre-existing vitamin D supplementation
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COPD | — | UNRESOLVED | — |
| Deficiency of Vitamin D3 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| multivitamin | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supplementation
- description
- 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.
- interventionNames
- Dietary Supplement: Cholecalciferol
- Dietary Supplement: multivitamin
- type
- ACTIVE_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Dietary Supplement: multivitamin
- Dietary Supplement: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 50 years old. 2. Current or ex-smoker with at least 10 pack-year history 3. COPD, GOLD II or greater (defined as FEV1/FVC \<70% and FEV1 % predicted \<80%) 4. 25(OH)D3 level ≤25 ng/mL 5. Willingness to comply with study guidelines. 6. Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial 7. 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. Exclusion Criteria: 1. Personal history of lung cancer or head and neck cancer 2. History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue). 3. History of known thyroid disease 4. History of known sarcoid disease 5. History of known abnormalities in calcium metabolism 6. Hypercalcemia (serum calcium in excess of laboratory ULN) 7. Self-reported consumption of more than 4 alcoholic drinks per day 8. Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism 9. History of known renal dysfunction 10. History of known nephrolithiasis (kidney stones) 11. Current participation in another cancer chemoprevention study 12. Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug. 13. Inability to swallow pills. 14. Vitamin D supplementation \> 2,000 IU/day of vitamin D within 30 days prior to enrollment. 15. Being pregnant
References
Publications (0)
Data not yet available