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
COMPLETED
PHASE1/PHASE2
98 participants
3 months
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
| 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
| 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
| 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=99 Participants
|
29.4 years
STANDARD_DEVIATION 13 • n=107 Participants
|
26 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Smokers
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsWe 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
| 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
Placebo Airway Surface Liquid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place