An interventional study of Zinc gluconate in HIV and Inflammation, sponsored by Grace McComsey. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Grace McComsey · Not applicable, Interventional, and Supportive care
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →This is the only study on the registry with Grace McComsey as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will take a daily 45 mg dose of zinc gluconate.
Dietary Supplement: Zinc gluconate
Participants in this arm will take a daily 90 mg dose of zinc gluconate.
Dietary Supplement: Zinc gluconate
Participants will take a daily dose of zinc gluconate.
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.
Time frame: Baseline and 16 Weeks
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.
Time frame: 16 Weeks
Participants were recruited based on physician referral at University Hospitals Cleveland Medical Center between September 2016 and February 2018.
| Milestone | 45 mg Daily | 90 mg Daily |
|---|---|---|
| Started | 25 | 27 |
| Completed | 24 | 24 |
| Not completed | 1 | 3 |
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.
| Participants | 45 mg Daily | 90 mg Daily |
|---|---|---|
| sCD14 | 15 | 15 |
| sTNF-RI | 14 | 15 |
| hs-CRP | 12 | 15 |
After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels \>75 μg/dL.
| percentage of participants | 45 mg Daily | 90 mg Daily |
|---|---|---|
| Percentage of Participants That Reached the Zinc Sufficient Level After Treatment | 88 | 96 |
Collected over 16 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 45 mg Daily | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| 90 mg Daily | 0/27 (0%) | 0/27 (0%) | 1/27 (3.7%) |
| Event | 45 mg Daily | 90 mg Daily |
|---|---|---|
| NauseaGastrointestinal disorders | 0/25 | 1/27 |
| Abdominal crampsGastrointestinal disorders | 0/25 | 1/27 |
| Age, Categorical(Participants) | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 1 | 24 |
| >=65 years | 2 | 26 | 28 |
| Age, Continuous(years) | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| Median | 54 (48 to 60) | 47 (38 to 54.50) | 49 (38 to 60) |
| Sex: Female, Male(Participants) | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 20 | 20 | 40 |
| Ethnicity (NIH/OMB)(Participants) | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 25 | 24 | 49 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 20 | 38 |
| White | 7 | 7 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| United States | 25 | 27 | 52 |
| Zinc levels(μg/dL) | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| Median | 74.00 (64.00 to 83.00) | 73.00 (66.00 to 86.00) | 73 (64 to 86) |
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Plan to share: No
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