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Trial Outcomes & Findings for Human Lung Responses to Respiratory Pathogens (NCT NCT01967628)

NCT ID: NCT01967628

Last Updated: 2018-03-29

Results Overview

We investigated the effect of vitamin D3 supplementation on airway surface liquid antimicrobial activity using a bioluminescent bacterial challenge. We challenged airway surface liquid samples with bioluminescent bacteria and measured live bacteria by relative light units (RLU) after 2 minutes as a surrogate of antimicrobial activity. We interpreted a reduction in live bacteria after challenge in relative light units as increased antimicrobial activity

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

98 participants

Primary outcome timeframe

3 months

Results posted on

2018-03-29

Participant Flow

Subjects were included if they were 18-60 years old and able to understand and sign a consent form. All study procedures were performed at the University of Iowa Hospitals and Clinics bronchoscopy lab and clinical research unit between May 2008 and July 2010.

Subjects were included if they were 18-60 years.Subjects were excluded if taking a multivitamin or vitamin D supplement within the previous three months, pregnant or breastfeeding,had a vaccination within one month, significant comorbid conditions, respiratory infection, history of positive tuberculin skin test, or use of antibiotics recently.

Participant milestones

Participant milestones
Measure
Vitamin D3
Vitamin D3 (1000 IUs) daily for 3 months. Vitamin D3 (cholecalciferol)
Sugar Capsule
Placebo comparator made of sugar in a capsule Placebo Sugar Pill
Overall Study
STARTED
48
50
Overall Study
COMPLETED
21
19
Overall Study
NOT COMPLETED
27
31

Reasons for withdrawal

Reasons for withdrawal
Measure
Vitamin D3
Vitamin D3 (1000 IUs) daily for 3 months. Vitamin D3 (cholecalciferol)
Sugar Capsule
Placebo comparator made of sugar in a capsule Placebo Sugar Pill
Overall Study
Withdrawal by Subject
2
0
Overall Study
Unable to complete bronchoscopy
4
6
Overall Study
Lost to Follow-up
1
0
Overall Study
Low protein concentration in sample
20
25

Baseline Characteristics

Human Lung Responses to Respiratory Pathogens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vitamin D ASL
n=21 Participants
Analysis of airway surface liquid in those taking Vitamin D
Placebo ASL
n=19 Participants
Analysis of airway surface liquid in those taking placebo.
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
25.8 years
STANDARD_DEVIATION 7.6 • n=93 Participants
29.4 years
STANDARD_DEVIATION 13 • n=4 Participants
26 years
STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male
Female
6 Participants
n=93 Participants
8 Participants
n=4 Participants
14 Participants
n=27 Participants
Sex: Female, Male
Male
15 Participants
n=93 Participants
11 Participants
n=4 Participants
26 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=93 Participants
3 Participants
n=4 Participants
4 Participants
n=27 Participants
Race (NIH/OMB)
White
20 Participants
n=93 Participants
16 Participants
n=4 Participants
36 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Smokers
5 Participants
n=93 Participants
7 Participants
n=4 Participants
12 Participants
n=27 Participants

PRIMARY outcome

Timeframe: 3 months

We investigated the effect of vitamin D3 supplementation on airway surface liquid antimicrobial activity using a bioluminescent bacterial challenge. We challenged airway surface liquid samples with bioluminescent bacteria and measured live bacteria by relative light units (RLU) after 2 minutes as a surrogate of antimicrobial activity. We interpreted a reduction in live bacteria after challenge in relative light units as increased antimicrobial activity

Outcome measures

Outcome measures
Measure
Vitamin D3
n=21 Participants
Vitamin D3 (cholecalciferol) at 1000 international units daily for 3 months
Sugar Capsule
n=19 Participants
Placebo comparator made of sugar in a capsule Placebo Sugar Pill
Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)
-581 Relative Light Units (RLU)
Interval -1122.0 to -40.0
-485 Relative Light Units (RLU)
Interval -1170.0 to 199.0

Adverse Events

Vitamin D Airway Surface Liquid

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Airway Surface Liquid

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alicia Gerke

University of Iowa

Phone: 319-356-1869

Results disclosure agreements

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