CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
Vitamin D3 (cholecalciferol) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01967628
NCT01967628Phase 2Completed

Human Lung Responses to Respiratory Pathogens

University of Iowa·interventional·Posted Oct 23, 2013·Updated Mar 29, 2018

In Brief

A Phase 2 clinical trial evaluating Vitamin D3 (cholecalciferol) and Placebo Sugar Pill for Respiratory Infection. Completed, enrolled 98 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 23, 2013
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.7 years ago

Interventions

Vitamin D3 (cholecalciferol)dietary

Placebo Sugar Pilldietary