---
title: Human Lung Responses to Respiratory Pathogens
nct_id: NCT01967628
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: University of Iowa
study_type: INTERVENTIONAL
primary_condition: Respiratory Infection
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01967628.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01967628"
ct_last_update_post_date: 2018-03-29
last_seen_at: "2026-05-12T06:31:29.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Human Lung Responses to Respiratory Pathogens

**NCT ID:** [NCT01967628](https://clinicaltrials.gov/study/NCT01967628)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 98
- **Lead Sponsor:** University of Iowa
- **Collaborators:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Conditions:** Respiratory Infection
- **Start Date:** 2007-06
- **Completion Date:** 2010-10
- **CT.gov Last Update:** 2018-03-29

## Brief Summary

For most individuals, the lung has a remarkable ability to deal with exposure to a variety of inhaled bacteria. Some individuals, however, do have recurrent bacterial infections, usually in the form of acute or chronic bronchitis and, in some instances, pneumonia. The reasons for this variability in bacterial infections between otherwise healthy subjects, between types of lung disease, and within the same type of lung disease are poorly understood.

Variability in susceptibility to bacterial infections is partially explained by differences in exposure to infectious agents, genetic susceptibility and innate (or early) immune responses. It is of interest that the incidence and severity of bacterial infections is greatest during the winter months. Other than viral infections, there are few variables that change with season. Vitamin D is one known immune modulator with a seasonal periodicity. The hypothesis of this study is that levels of vitamin D are an important determinant of the innate defense of the lung against inhaled bacteria. The investigators further postulate that vitamin D has effects on the innate immune function of both alveolar macrophages and lung epithelial cells.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

Signed informed consent form Age 18 - 60 Healthy nonsmoker, healthy smoker Forced expiratory volume in 1 second (for smokers) \> 60% predicted.

Exclusion Criteria:

* Pregnant or breastfeeding
* Medications (with the exception of hormonal birth control, thyroid medication or prespecified over the counter medications), including multi-vitamins and any preparation that contains vitamin D
* Asthma
* Heart disease
* Diabetes
* Previous positive tuberculin skin test, or previous diagnosis of tuberculosis
* Recent respiratory tract infection
* History of multiple bouts of pneumonia
* Allergies to caines, atropine, or a history of adverse reaction to narcotics
* Other factors that increase the risk of bronchoscopy
* Evidence of acute bronchitis within the past 2 weeks
```

## Arms

- **Vitamin D3 (cholecalciferol)** (EXPERIMENTAL) — Vitamin D3 (1000 international units) daily for 3 months.
- **Sugar capsule** (PLACEBO_COMPARATOR) — Placebo comparator made of sugar in a capsule

## Interventions

- **Vitamin D3 (cholecalciferol)** (DIETARY_SUPPLEMENT)
- **Placebo Sugar Pill** (DIETARY_SUPPLEMENT)

## Primary Outcomes

- **Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)** _(time frame: 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

## Locations (1)

- University of Iowa, Iowa City, Iowa, United States

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of iowa|iowa city|iowa|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01967628.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01967628*  
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