HIV/AIDSPhase 1NCT03270709

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

A Phase 1 study testing Vitamin D3 450,000 IU orally in people with HIV/AIDS and Vitamin D Deficiency, run by Emory University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV/AIDS, Vitamin D Deficiency, Smoker Lung
What is being tested?: Vitamin D3 450,000 IU orally
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 2 sitesUnited States
Study dates: 11 Apr 2018to 15 Oct 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 9Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Atlanta VA Medical center
Atlanta, Georgia, 30303
Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center
Atlanta, Georgia, 30303

Other trials in United States

About this study

Official title: Effect of High-Dose Vitamin D3 on Alveolar Macrophage Function, LL-37, and Oxidative Stress in Smokers and Non-Smokers With and Without HIV

Read the 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+ 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.

Conditions: HIV/AIDS, Vitamin D Deficiency, Smoker Lung
Being tested: Vitamin D3 450,000 IU orally
Keywords: Vitamin D3, Pulmonary disease, Immunosuppression, HIV, Smoking
Medical subject headings: Acquired Immunodeficiency Syndrome, Vitamin D Deficiency, Lung Diseases, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3 450,000 IU orallyDrug
Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.

Study groups in NCT03270709
Study group	Role	What they receive
HIV+ smokers	Experimental	Vitamin D3 450,000 IU orally Receives: Drug: Vitamin D3 450,000 IU orally
HIV- non-smokers	Active comparator	Vitamin D3 450,000 IU orally Receives: Drug: Vitamin D3 450,000 IU orally
HIV+ non-smokers	Active comparator	Vitamin D3 450,000 IU orally Receives: Drug: Vitamin D3 450,000 IU orally
HIV- smokers	Active comparator	Vitamin D3 450,000 IU orally Receives: Drug: Vitamin D3 450,000 IU orally

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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) .
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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) .
Measured: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 201815 Oct 2018

First posted1 Sep 2017
Study start11 Apr 2018
Primary completion15 Oct 2018
Study completion15 Oct 2018

Why it stopped: Study terminated early due to lack of funding and the COVID-19 pandemic.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: A total of 44 subjects (11 per group, smokers and non-smokers, HIV+, HIV-) will be enrolled.
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03270709
Sponsor's protocol ID: IRB00094833
Status last verified: Apr 2021
First submitted: 31 Aug 2017
Last updated: 21 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV/AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of High-Dose Vitamin D3 on Alveolar Macrophage Function, LL-37, and Oxidative Stress in Smokers and Non-Smokers With and Without HIV
ClinicalTrials.gov ID: NCT03270709
Acronym / sponsor ID: IRB00094833
Conditions: HIV/AIDS, Vitamin D Deficiency, Smoker Lung
Keywords: Vitamin D3, Pulmonary disease, Immunosuppression, HIV, Smoking
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated early due to lack of funding and the COVID-19 pandemic.
Enrolment: 7 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 11 Apr 2018 (actual)
Primary completion: 15 Oct 2018 (actual)
Study completion: 15 Oct 2018 (actual)
First posted: 1 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: A total of 44 subjects (11 per group, smokers and non-smokers, HIV+, HIV-) will be enrolled.

Arm	Type	Receives
HIV+ smokers	Experimental	Drug: Vitamin D3 450,000 IU orallyVitamin D3 450,000 IU orally
HIV- non-smokers	Active comparator	Drug: Vitamin D3 450,000 IU orallyVitamin D3 450,000 IU orally
HIV+ non-smokers	Active comparator	Drug: Vitamin D3 450,000 IU orallyVitamin D3 450,000 IU orally
HIV- smokers	Active comparator	Drug: Vitamin D3 450,000 IU orallyVitamin D3 450,000 IU orally

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3 450,000 IU orallyStudy subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.	Drug	HIV+ non-smokers, HIV+ smokers, HIV- non-smokers, HIV- smokers

Primary outcome

Difference in alveolar macrophage (AM) phagocytic index between HIV+ smokers compared to HIV- non-smokers.
Time frame: Day 1 of the study prior to vitamin D administration.
A phagocytic index will be determined by challenging AM isolated from bronchoalveolar lavage (BAL) to Staph. Aureus in vitro.
Difference in phagocytosis percent positive between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
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 will be calculated.
Difference in alveolar macrophage (AM) phagocytic index before and after vitamin D administration.
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration
A phagocytic index will be determined by challenging AM isolated from bronchoalveolar lavage (BAL) to Staph. Aureus in vitro.

10 secondary outcomes

Difference in total and free vitamin D (25(OH) D) between HIV+ smokers compared to HIV- non-smokers, prior to vitamin D administration.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Day 1 of the study prior to vitamin D administration, Day 7 after vitamin D administration

Results and safety

The study was stopped early (reason given: Study terminated early due to lack of funding and the COVID-19 pandemic.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
Individual participant dataSharing planned: Undecided

Related trials for HIV/AIDS

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jenny E Han, MD, MSc principal investigator

Emory University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin D3 450,000 IU orally in people with HIV/AIDS and Vitamin D Deficiency, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated early due to lack of funding and the COVID-19 pandemic.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in alveolar macrophage (AM) phagocytic index between HIV+ smokers compared to HIV- non-smokers. (time frame: Day 1 of the study prior to vitamin D administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03270709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.