Trial Outcomes & Findings for Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD (NCT NCT02464059)

NCT ID: NCT02464059

Last Updated: 2020-07-24

Results Overview

Change from baseline to 8 weeks in bronchoscopic lavage lung cathelicidin levels after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2020-07-24

Participant Flow

Dates of recruitment: 11/10/2015-11/15/2018

Participant milestones

Measure	Vitamin D3 Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Overall Study STARTED	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Vitamin D3 Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Overall Study Lost to Follow-up	6

Baseline Characteristics

Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD

Baseline characteristics by cohort

Measure	Vitamin D3 n=23 Participants Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	52.8 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Analysis population represents N=17 participants who completed all study procedures

Change from baseline to 8 weeks in bronchoscopic lavage lung cathelicidin levels after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures)

Outcome measures

Measure	Vitamin D3 n=17 Participants Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Change From Baseline in Lung Cathelicidin Level at 8 Weeks	-65.5 pg/mL Interval -172.4 to 41.3

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Analysis population represents N=17 participants who completed all study procedures

Change from baseline to 8 weeks in blood cathelicidin levels after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures)

Outcome measures

Measure	Vitamin D3 n=17 Participants Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Change From Baseline in Blood Cathelicidin at 8 Weeks	-0.55 ng/ml Standard Deviation 12.6

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: The outcome measure of Vitamin D Binding Protein was not collected nor assessed on any study participants. This was due to technical limitations related to the assay.

Change from baseline to 8 weeks in blood vitamin D binding protein after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures)

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D3

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Vitamin D3 n=23 participants at risk Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks Vitamin D3: Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
General disorders Death after house fire	4.3% 1/23 • Number of events 1 • Adverse event data were collected from the time of informed consent until final bronchoscopy procedure, an approximate total of 8 weeks.

Other adverse events

Adverse event data not reported

Additional Information

Michael Bradley Drummond, MD

University of North Carolina at Chapel Hill

Phone: 919-966-7054

Email: brad_drummond@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place