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

NCT02532062 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-06-26

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

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

DIETARY_SUPPLEMENT

multivitamin

oral, once a day for one year

DIETARY_SUPPLEMENT

Placebo

oral, once a day for one year

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • David Wilson, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-01-01
Completion
2018-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532062 on ClinicalTrials.gov