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

Stopped early · Phase 1

Conditions studied: HIV/AIDS, Vitamin D Deficiency, Smoker Lung

In brief

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.

Key facts

Study ID

NCT03270709

Run by

Emory University

People needed

7

Starts

2018-04-11

Expected to finish

2018-10-15

Last updated by the study team

2021-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Atlanta VA Medical center — Atlanta, Georgia, United States
• Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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