Human Lung Responses to Respiratory Pathogens

NCT01967628 | Completed Phase 1 Results DMC

• 2 other identifiers: DMID 06-0003N01AI30040-11-0-0
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infection

Keywords

Vitamin D; Respiratory infection; Innate immunity

Outcome Measures

Primary Outcomes (1)

• Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)

  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

  3 months

Study Arms (2)

Vitamin D3 (cholecalciferol)

EXPERIMENTAL

Vitamin D3 (1000 international units) daily for 3 months.

Dietary Supplement: Vitamin D3 (cholecalciferol)

Sugar capsule

PLACEBO COMPARATOR

Placebo comparator made of sugar in a capsule

Dietary Supplement: Placebo Sugar Pill

Interventions

Vitamin D3 (cholecalciferol) DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol)

Placebo Sugar Pill DIETARY_SUPPLEMENT

Sugar capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Vargas Buonfiglio LG, Cano M, Pezzulo AA, Vanegas Calderon OG, Zabner J, Gerke AK, Comellas AP. Effect of vitamin D3 on the antimicrobial activity of human airway surface liquid: preliminary results of a randomised placebo-controlled double-blind trial. BMJ Open Respir Res. 2017 Jun 4;4(1):e000211. doi: 10.1136/bmjresp-2017-000211. eCollection 2017.

  PMID: 28883932 DERIVED

• Gerke AK, Pezzulo AA, Tang F, Cavanaugh JE, Bair TB, Phillips E, Powers LS, Monick MM. Effects of vitamin D supplementation on alveolar macrophage gene expression: preliminary results of a randomized, controlled trial. Multidiscip Respir Med. 2014 Mar 26;9(1):18. doi: 10.1186/2049-6958-9-18.

  PMID: 24669961 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Alicia Gerke
• Organization: University of Iowa

alicia-gerke@uiowa.edu

319-356-1869

Study Officials

• Alicia K Gerke, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 23, 2013
• Study Start: June 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 29, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-02

Locations

US (1)