NCT02877641

Cholecalciferol Supplementation in Strengthening Inspiratory Muscles in Cholecalciferol-Deficient Patients With Chronic Obstructive Pulmonary Disease

Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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). 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: I. 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: I. 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: I. 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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Muscle Weakness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIETARY_SUPPLEMENT	Multivitamin	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2014-04-16
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-08-24
• Last updated: 2017-02-15

Locations

1 site across 1 country: United States