A Phase 1 interventional study of Vitamin D3 450,000 IU orally in HIV/AIDS, Vitamin D Deficiency and Smoker Lung, sponsored by Emory University. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by Emory University · Phase 1, Interventional, and Treatment
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Among 38 studies in Acquired Immunodeficiency Syndrome by Emory University — 5 open to participants now, 8 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · Emory University.
Among the 38 studies in Acquired Immunodeficiency Syndrome by Emory University, this one is the 31st largest by enrollment of the 32 interventional ones that give a count, is one of 3 that started in 2018, is one of 4 in phase 1, and was the 19th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →5 of the 38 studies in Acquired Immunodeficiency Syndrome by Emory University are open now, in 1 country. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 18–65
Emory University · Sites in United States
Ages 18–75
Emory University · Sites in United States
Ages 18+ · Healthy volunteers
Emory University · Sites in United States
Ages 18+
Emory University · Sites in United States
Ages 21+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 3 · Phase 4 4
First in 2004; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 71 across the 32 interventional studies, 149 across the 6 observational. Of the 30 that completed or were terminated, 14 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
Emory University is the lead sponsor of 1,405 studies on the registry; 223 are open to participants now.
Of its 238 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
3 of the studies in Acquired Immunodeficiency Syndrome by Emory University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT05537935Emory UniversityLow Dose Naltrexone for Pain in Patients With HIV | 2027-06-30 |
| NCT05849038Emory UniversityInflammation and Depression in People With HIV | 2027-11 |
Add all 3 to your calendar (.ics) → With an account.
Among the 38 studies in Acquired Immunodeficiency Syndrome by Emory University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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+ smokers compared to HIV+ non-smokers, suggesting that smoking enhances HIV-1 viral replication in macrophages, which contributes to disease progression. Vitamin D deficiency has been associated with increased mortality in HIV+ persons, but there is limited research on how this is impacting the health of these highest risk patients and if aggressive repletion with vitamin D can improve overall health.The study team hypothesizes that vitamin D administration will increase pathogen clearance and improve innate immune function.
The proposed pre and post interventional study is designed to characterize alveolar macrophage function and lung immunity according to tobacco use and HIV status, and determine the impact of high dose oral vitamin D3 on AM phagocytic function and innate immunity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin D3 450,000 IU orally
Drug: Vitamin D3 450,000 IU orally
Vitamin D3 450,000 IU orally
Drug: Vitamin D3 450,000 IU orally
Vitamin D3 450,000 IU orally
Drug: Vitamin D3 450,000 IU orally
Vitamin D3 450,000 IU orally
Drug: Vitamin D3 450,000 IU orally
Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
Difference in total and free vitamin D (25(OH) D) between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
Difference in total and free 25(OH) D between HIV+ smokers compared to HIV- non-smokers will be measure by ELISA (enzyme-linked immunosorbent assay) levels.
Time frame: 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.
Difference in an antimicrobial and immunostimulating/-modulating peptide LL-37 between HIV+ smokers compared to HIV- non-smokers will be calculated.
Time frame: 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.
Difference in tumor necrosis factor alpha (TNF-α) - cytokine involved in systemic inflammation - between HIV+ smokers compared to HIV- non-smokers will be calculated .
Time frame: 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.
Difference in mRNA expression of antimicrobial peptide LL-37 between HIV+ smokers compared to HIV- non-smokers will be calculated.
Time frame: 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.
Difference in alveolar oxidative stress between HIV+ smokers compared to HIV- non-smokers will be measured using AM isolated from bronchoalveolar lavage (BAL) .
Time frame: Day 1 of the study prior to vitamin D administration.
Difference in total and free vitamin D (25(OH) D) before and after vitamin D administration.
Difference in total and free vitamin D (25(OH) D) will be measure by ELISA (enzyme-linked immunosorbent assay)
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
Difference in peptide LL-37 before and after vitamin D administration.
Difference in peptide LL-37 levels will be calculated.
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
Difference in tumor necrosis factor alpha (TNF-α) before and after vitamin D administration.
Difference in tumor necrosis factor alpha (TNF-α) will be calculated.
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
Difference in mRNA expression of LL-37 before and after vitamin D administration.
Difference in mRNA expression of LL-37 will be calculated.
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
Difference in alveolar oxidative stress before and after vitamin D administration.
Difference in alveolar oxidative stress will be measured using AM isolated from bronchoalveolar lavage (BAL) .
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Oct 2018, 6 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →