Study Stopped
Study terminated early due to lack of funding and the COVID-19 pandemic.
Effect of High-Dose Vitamin D3 in Smokers and Non-Smokers With and Without HIV
1 other identifier
interventional
7
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2018
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedStudy Start
First participant enrolled
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2018
CompletedApril 21, 2021
April 1, 2021
6 months
August 31, 2017
April 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Difference in alveolar macrophage (AM) phagocytic index between HIV+ smokers compared to HIV- non-smokers.
A phagocytic index will be determined by challenging AM isolated from bronchoalveolar lavage (BAL) to Staph. Aureus in vitro.
Day 1 of the study prior to vitamin D administration.
Difference in phagocytosis percent positive between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
Difference in phagocytosis percent positive between HIV+ smokers compared to HIV- non-smokers will be calculated.
Day 1 of the study prior to vitamin D administration.
Difference in alveolar macrophage (AM) phagocytic index before and after vitamin D administration.
A phagocytic index will be determined by challenging AM isolated from bronchoalveolar lavage (BAL) to Staph. Aureus in vitro.
Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
Secondary Outcomes (10)
Difference in total and free vitamin D (25(OH) D) between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
Day 1 of the study prior to vitamin D administration.
Difference in peptide LL-37 between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
Day 1 of the study prior to vitamin D administration.
Difference in tumor necrosis factor alpha (TNF-α) between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
Day 1 of the study prior to vitamin D administration.
Difference in messenger ribonucleic acid (mRNA) expression of LL-37 between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
Day 1 of the study prior to vitamin D administration.
Difference in alveolar oxidative stress between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
Day 1 of the study prior to vitamin D administration.
- +5 more secondary outcomes
Study Arms (4)
HIV+ smokers
EXPERIMENTALVitamin D3 450,000 IU orally
HIV- non-smokers
ACTIVE COMPARATORVitamin D3 450,000 IU orally
HIV+ non-smokers
ACTIVE COMPARATORVitamin D3 450,000 IU orally
HIV- smokers
ACTIVE COMPARATORVitamin D3 450,000 IU orally
Interventions
Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (2)
Atlanta VA Medical center
Atlanta, Georgia, 30303, United States
Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center
Atlanta, Georgia, 30303, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jenny E Han, MD, MSc
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 31, 2017
First Posted
September 1, 2017
Study Start
April 11, 2018
Primary Completion
October 15, 2018
Study Completion
October 15, 2018
Last Updated
April 21, 2021
Record last verified: 2021-04