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

NCT02877641 | Terminated Phase 2 DMC

• 4 other identifiers: I 240913NCI-2016-00524P30CA016056P50CA090440
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Muscle Weakness

Keywords

Current Smoker; Former Smoker

Outcome Measures

Primary Outcomes (2)

• Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)

  75% will be considered a success.

  At 12 months

• Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study)

  Will be analyzed using linear mixed model by regressing the repeated outcome on the group indicator (treatment or control) and other appropriate covariates. Appropriate within-subject covariance will be determined from an exploratory study. The effect of vitamin D3 supplementation will be tested using an approximate t-test.

  Baseline to 24 weeks

Secondary Outcomes (5)

• Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study)

  Baseline to 24 weeks

• Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study)

  Baseline to 24 weeks

• Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)

  At 3 months

• Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)

  At 6 months

• Change in peripheral muscle strength assessed by squat test (RPCI/UB study)

  Baseline to 24 weeks

Other Outcomes (1)

• Change in correlative biomarkers of lung cancer risk, inflammation, and pulmonary function (UPCI study)

  Baseline to up to 1 year

Study Arms (2)

Control arm (multivitamin, placebo)

ACTIVE COMPARATOR

Patients receive a placebo and multivitamin orally each day for 52 weeks.

Other: Laboratory Biomarker Analysis; Dietary Supplement: Multivitamin; Other: Placebo; Other: Questionnaire Administration

Supplementation arm (multivitamin, cholecalciferol)

EXPERIMENTAL

Patients receive a multivitamin and cholecalciferol supplement orally each day for 52 weeks.

Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis; Dietary Supplement: Multivitamin; Other: Questionnaire Administration

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3

Supplementation arm (multivitamin, cholecalciferol)

Laboratory Biomarker Analysis OTHER

Correlative studies

Control arm (multivitamin, placebo); Supplementation arm (multivitamin, cholecalciferol)

Multivitamin DIETARY_SUPPLEMENT

Given PO

Also known as: Geritol, Vitamin Supplements (NOS)

Control arm (multivitamin, placebo); Supplementation arm (multivitamin, cholecalciferol)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Control arm (multivitamin, placebo)

Questionnaire Administration OTHER

Ancillary studies

Control arm (multivitamin, placebo); Supplementation arm (multivitamin, cholecalciferol)

Eligibility Criteria

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

You may qualify if:

• Current or ex-smoker with at least a 10-year pack history
• COPD, defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \< 70% and FEV1% predicted \< 80%
• hydroxy vitamin D3 (25\[OH\]D3) level less than 20 ng/mL prior to study initiation
• Willingness to comply with study guidelines
• Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
• Subject 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 upper limit normal \[ULN\])
• 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 use of supplemental oxygen
• Inability to exercise due to musculoskeletal issue, osteoarthritis or underlying cardiac disease
• Current participation in a cancer intervention prevention study, except for smoking cessation
• Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
• Inability to swallow pills

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Muscle Weakness; Smoking Cessation

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; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Martin Mahoney

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 24, 2016
• Study Start: April 16, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

US (1)