Effect of High-Dose Vitamin D3 in Smokers and Non-Smokers With and Without HIV



Status:Recruiting
Conditions:Other Indications, HIV / AIDS, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:April 11, 2018
End Date:June 1, 2020
Contact:Jenny E Han, MD, MSc
Email:jehan2@emory.edu
Phone:4046160821

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Effect of High-Dose Vitamin D3 on Alveolar Macrophage Function, LL-37, and Oxidative Stress in Smokers and Non-Smokers With and Without HIV

Supplementation with vitamin D improves HIV+ macrophages phagocytosis in vitro. There is
evidence to suggest that administering vitamin D can in fact improve immune function in
individuals. The study will evaluate the impact of high dose vitamin D in HIV+ smokers' and
HIV- smokers' in vivo. The primary goal is to improve innate immune host response to
infection in patients already at high risk by virtue of HIV and smoking status.

Tobacco smoke suppresses the lung's ability to fight infection. Smoking is three times more
prevalent in the HIV+ compared to HIV- patients. Viral load was found to be significantly
increased in HIV+ smokers compared to HIV+ non-smokers, suggesting that smoking enhances
HIV-1 viral replication in macrophages, which contributes to disease progression. Vitamin D
deficiency has been associated with increased mortality in HIV+ persons, but there is limited
research on how this is impacting the health of these highest risk patients and if aggressive
repletion with vitamin D can improve overall health.The study team hypothesizes that vitamin
D administration will increase pathogen clearance and improve innate immune function.

The proposed pre and post interventional study is designed to characterize alveolar
macrophage function and lung immunity according to tobacco use and HIV status, and determine
the impact of high dose oral vitamin D3 on AM phagocytic function and innate immunity.

Inclusion Criteria:

- Subjects living with HIV-1 infection who have been on anti-retroviral therapy (ART)
for a minimum of 12 months and are followed longitudinally for their HIV healthcare;

- Ability to give informed consent.

Exclusion Criteria:

- Age <18 yrs old;

- Known or possible pregnancy or breastfeeding;

- Documented history of cirrhosis or a direct bilirubin ≥ 2.0 mg/dL;

- Documentation of left ventricular ejection fraction < 40% or myocardial infarction
within the past 6 months;

- End-stage renal disease requiring dialysis or a serum creatinine ≥ 2 mg/d;

- Spirometry with FVC or FEV1< 70% of predicted value;

- Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding
within the past year;

- Inability to undergo bronchoscopy safely;

- High risk behaviors without known HIV status.
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303 Parkway Drive Northeast
Atlanta, Georgia 30033
Phone: 404-321-6111
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80 Jesse Hill Junior Drive Southeast
Atlanta, Georgia 30303
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