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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AT009153-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 45 mg daily | Active Comparator | Participants in this arm will take a daily 45 mg dose of zinc gluconate. |
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| 90 mg daily | Active Comparator | Participants in this arm will take a daily 90 mg dose of zinc gluconate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc gluconate | Dietary Supplement | Participants will take a daily dose of zinc gluconate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace McComsey, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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Of 118 patients screened, 52 met inclusion criteria and were randomized to treatment.
Participants were recruited based on physician referral at University Hospitals Cleveland Medical Center between September 2016 and February 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 45 mg Daily | Participants in this arm will take a daily 45 mg dose of zinc gluconate. Zinc gluconate: Participants will take a daily dose of zinc gluconate. |
| FG001 | 90 mg Daily | Participants in this arm will take a daily 90 mg dose of zinc gluconate. Zinc gluconate: Participants will take a daily dose of zinc gluconate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 45 mg Daily | Participants in this arm will take a daily 45 mg dose of zinc gluconate. Zinc gluconate: Participants will take a daily dose of zinc gluconate. |
| BG001 | 90 mg Daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat population (all participants assigned to zinc 45 mmg or zinc 90 mg). | Posted | Count of Participants | Participants | Baseline and 16 Weeks |
|
16 Weeks
At entry, weeks 4,10, and 16, All-Cause Mortality and Serious Adverse Events were assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 45 mg Daily | Participants in this arm take a daily 45 mg dose of zinc gluconate. Participants were interviewed for side effects at baseline and at week 16. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace McComsey | University Hospitals Cleveland Medical Center | 216-8442739 | Grace.McComsey@UHhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2016 | Aug 18, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2017 | Aug 18, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C030691 | gluconic acid |
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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.
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Patients and the research nurse are unblinded. The research assistant and the principle investigator are blinded.
Participants in this arm will take a daily 90 mg dose of zinc gluconate.
Zinc gluconate: Participants will take a daily dose of zinc gluconate.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Zinc levels | Median and Inter-Quartile range of zinc blood levels in μg/dL | Median | Inter-Quartile Range | μg/dL |
|
| 90 mg Daily |
Participants in this arm will take a daily 90 mg dose of zinc gluconate. Zinc gluconate: Participants will take a daily dose of zinc gluconate. |
|
|
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| Secondary | 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. | Posted | Number | percentage of participants | 16 Weeks |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 90 mg Daily | Participants in this arm take a daily 90 mg dose of zinc gluconate. Participants were interviewed for side effects at baseline and at week 16. | 0 | 27 | 0 | 27 | 1 | 27 |
| Abdominal cramps | Gastrointestinal disorders | Non-systematic Assessment |
|
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