HIVNCT02856269

Zinc Supplementation and Cardiovascular Risk in HIV

A study testing Zinc gluconate in people with HIV and Inflammation, run by Grace McComsey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, Inflammation
What is being tested?: Zinc gluconate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Sep 2016to 16 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

HIV-1 infection
Age ≥18 years
Zinc level ≤0.75 mg/L
Receiving a stable antiretroviral regimen with no plans to change during study
Documentation of an HIV-1 RNA level of ≤400 copies/mL
No diarrhea or nausea/vomiting for the last month

Who cannot join

Pregnancy/lactation
Presence of inflammatory condition
Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
Known cardiovascular disease
Uncontrolled diabetes

Show all 10Show fewer

Allergy or intolerance to zinc sulfate.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x Upper limit of normal (ULN)
Hemoglobin < 9.0 g/dL
glomerular filtration rate (GFR) < 50 mL/min

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

Read the detailed description

Zinc is a dietary supplement with compelling preclinical evidence for potential health benefit that could be expanded not only to the entire HIV population, but also to other inflammatory conditions that share many facets of HIV infection, namely the persistent intestinal barrier dysfunction, monocyte activation and heightened inflammation state.

Conditions: HIV, Inflammation
Being tested: Zinc gluconate
Keywords: Zinc
Medical subject headings: Inflammation

What participants receive

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

Zinc gluconateDietary supplement
Participants will take a daily dose of zinc gluconate.

Study groups in NCT02856269
Study group	Role	What they receive
45 mg daily	Active comparator	Participants in this arm will take a daily 45 mg dose of zinc gluconate. Receives: Dietary Supplement: Zinc gluconate
90 mg daily	Active comparator	Participants in this arm will take a daily 90 mg dose of zinc gluconate. Receives: Dietary Supplement: Zinc gluconate

What is being measured

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

Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
Percentage of participants with the following inflammatory markers decrease (sCD14) Soluble cluster of differentiation 14, (sTNF-RI) soluble Tumor Necrosis Factor alpha receptor I, (hs-CRP) High sensitivity C-reactive protein. These inflammatory markers are measured in the blood by enzyme-linked immunoassay ELISA.
Measured: Baseline and 16 Weeks

Secondary outcomes (1)

Percentage of Participants That Reached the Zinc Sufficient Level After Treatment
After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels >75 μg/dL.
Measured: 16 Weeks

Timeline

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

Sep 201616 Apr 2018

First posted4 Aug 2016 (estimated)
Study startSep 2016
Primary completion16 Apr 2018
Study completion16 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a pilot open labeled randomized double arm trial, studying zinc supplementation to prevent HIV comorbidities that are linked to inflammation. Patients will be given zinc gluconate 45 mg capsule once daily in one arm, and 90 mg zinc gluconate in the other arm for 16 weeks.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02856269
Sponsor's protocol ID: 02-15-07
Other IDs: 1R21AT009153-01
Status last verified: Feb 2022
First submitted: 29 Jul 2016
Last updated: 11 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Zinc Supplementation and Cardiovascular Risk in HIV
ClinicalTrials.gov ID: NCT02856269
Acronym / sponsor ID: 02-15-07
Conditions: HIV, Inflammation
Keywords: Zinc
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Grace McComseyUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Sep 2016
Primary completion: 16 Apr 2018 (actual)
Study completion: 16 Apr 2018 (actual)
First posted: 4 Aug 2016 (estimated)
Results: Posted 11 Feb 2022

Clinical summary

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

The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: This is a pilot open labeled randomized double arm trial, studying zinc supplementation to prevent HIV comorbidities that are linked to inflammation. Patients will be given zinc gluconate 45 mg capsule once daily in one arm, and 90 mg zinc gluconate in the other arm for 16 weeks.

Arm	Type	Receives
45 mg daily	Active comparator	Dietary Supplement: Zinc gluconateParticipants in this arm will take a daily 45 mg dose of zinc gluconate.
90 mg daily	Active comparator	Dietary Supplement: Zinc gluconateParticipants in this arm will take a daily 90 mg dose of zinc gluconate.

Who may qualify

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

Key inclusion criteria (6 listed)

HIV-1 infection
Age ≥18 years
Zinc level ≤0.75 mg/L
Receiving a stable antiretroviral regimen with no plans to change during study
Documentation of an HIV-1 RNA level of ≤400 copies/mL

Key exclusion criteria (10 listed)

Pregnancy/lactation
Presence of inflammatory condition
Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
Known cardiovascular disease

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
Zinc gluconateParticipants will take a daily dose of zinc gluconate.	Dietary supplement	45 mg daily, 90 mg daily

Primary outcome

Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
Time frame: Baseline and 16 Weeks
Percentage of participants with the following inflammatory markers decrease (sCD14) Soluble cluster of differentiation 14, (sTNF-RI) soluble Tumor Necrosis Factor alpha receptor I, (hs-CRP) High sensitivity C-reactive protein. These inflammatory markers are measured in the blood by enzyme-linked immunoassay ELISA.

1 secondary outcome

Percentage of Participants That Reached the Zinc Sufficient Level After Treatment
Time frame: 16 Weeks

Results and safety

Results posted to the registry on 11 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
45 mg Daily	25	24
90 mg Daily	27	24

Primary outcome: Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)

Time frame: Baseline and 16 Weeks. Count of participants. Unit: Participants

Measure	45 mg Daily n = 25	90 mg Daily n = 27
sCD14	15	15
sTNF-RI	14	15
hs-CRP	12	15

45 mg Daily vs 90 mg Daily: Cohen's D value: 0.8

Population analysed: Intent to treat population (all participants assigned to zinc 45 mmg or zinc 90 mg).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 16 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
45 mg Daily	0 of 25 (0%)	0 of 25 (0%)	0 of 25
90 mg Daily	0 of 27 (0%)	1 of 27 (3.7%)	0 of 27

Limitations and caveats (from the sponsor): Due to the small sample size and short study period, we cannot establish causation. We did not include a placebo control group for comparison. Our study focused on participants with treated HIV and documented zinc deficiency in the United States. We did not obtain dietary or physical activity patterns. Participants with treated HIV and documented zinc deficiency resided in the United States, therefore our findings cannot be generalized to different populations or to resource limited settings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Grace McComsey, MD principal investigator

University Hospitals Cleveland Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing Zinc gluconate in people with HIV and Inflammation, run by Grace McComsey at 1 site 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) (time frame: Baseline and 16 Weeks). 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 NCT02856269.

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 11 Feb 2022.