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.