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

Emory University

Status and phase: Terminated; Phase 1

Conditions: Smoker Lung; Vitamin D Deficiency; HIV/AIDS

Treatments: Drug: Vitamin D3 450,000 IU orally

Study type: Interventional

Funder types: Other

Identifiers

NCT03270709

IRB00094833

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 forced vital capacity (FVC) or forced expiratory volume (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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 4 patient groups

HIV+ smokers

Experimental group

Description:

Vitamin D3 450,000 IU orally

Treatment:

Drug: Vitamin D3 450,000 IU orally

HIV- non-smokers

Active Comparator group

Description:

Vitamin D3 450,000 IU orally

Treatment:

Drug: Vitamin D3 450,000 IU orally

HIV+ non-smokers

Active Comparator group

Description:

Vitamin D3 450,000 IU orally

Treatment:

Drug: Vitamin D3 450,000 IU orally

HIV- smokers

Active Comparator group

Description:

Vitamin D3 450,000 IU orally

Treatment:

Drug: Vitamin D3 450,000 IU orally