The Pittsburgh Vitamin D Study: Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer

NCT02532062 | Terminated DMC

• 2 other identifiers: PRO15020031P50CA090440
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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

Deficiency of Vitamin D3; COPD

Keywords

lung cancer risk; cigarette smokers

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (6)

• The 3-month conversion rate

  3 months

• The 6-month conversion rate

  6 months

• Pulmonary function as measured by spirometry

  12 months

• Promoter methylation status in sputum and nasal swab samples

  12 months

• Protein expression in sputum and nasal swab samples

  12 months

Study Arms (2)

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.

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.

Dietary Supplement: multivitamin; Dietary Supplement: Placebo

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

4,000 IU, oral, once a day for one year

Also known as: Vitamin D3

Supplementation

multivitamin DIETARY_SUPPLEMENT

oral, once a day for one year

Placebo; Supplementation

Placebo DIETARY_SUPPLEMENT

oral, once a day for one year

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)
• (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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cholecalciferol; Geritol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• David Wilson, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, Associate Professor of Medicine

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 25, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

US (1)