Overview

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

Status:
Terminated
Trial end date:
2018-10-15
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
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.