Status:
TERMINATED
Effect of High-Dose Vitamin D3 in Smokers and Non-Smokers With and Without HIV
Lead Sponsor:
Emory University
Conditions:
HIV/AIDS
Vitamin D Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed 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+ ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03270709
Start Date
April 11 2018
End Date
October 15 2018
Last Update
April 21 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlanta VA Medical center
Atlanta, Georgia, United States, 30303
2
Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center
Atlanta, Georgia, United States, 30303