HIV, Inflammation
Conditions
Keywords
Zinc
Brief summary
The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.
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.
Interventions
DIETARY_SUPPLEMENTZinc gluconate
Participants will take a daily dose of zinc gluconate.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Grace McComsey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Patients and the research nurse are unblinded. The research assistant and the principle investigator are blinded.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Reached the Zinc Sufficient Level After Treatment | 16 Weeks | After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels \>75 μg/dL. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at University Hospitals Cleveland Medical Center between September 2016 and February 2018.
Pre-assignment details
Of 118 patients screened, 52 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 27 |
| Total | 52 |
Baseline characteristics
| Characteristic | 45 mg Daily | 90 mg Daily | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 26 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 1 Participants | 24 Participants |
| Age, Continuous | 54 years | 47 years | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 24 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 20 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 25 participants | 27 participants | 52 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
| Zinc levels | 74.00 μg/dL | 73.00 μg/dL | 73 μg/dL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 0 / 25 | 1 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
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.
Time frame: Baseline and 16 Weeks
Population: Intent to treat population (all participants assigned to zinc 45 mmg or zinc 90 mg).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 45 mg Daily | Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | sCD14 | 15 Participants |
| 45 mg Daily | Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | sTNF-RI | 14 Participants |
| 45 mg Daily | Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | hs-CRP | 12 Participants |
| 90 mg Daily | Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | sCD14 | 15 Participants |
| 90 mg Daily | Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | sTNF-RI | 15 Participants |
| 90 mg Daily | Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | hs-CRP | 15 Participants |
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.
Time frame: 16 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 45 mg Daily | Percentage of Participants That Reached the Zinc Sufficient Level After Treatment | 88 percentage of participants |
| 90 mg Daily | Percentage of Participants That Reached the Zinc Sufficient Level After Treatment | 96 percentage of participants |