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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AT009153 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy
This study will focus on subjects with documented zinc deficiency (levels <75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc gluconate | Experimental | Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. |
|
| Placebo | Placebo Comparator | Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Gluconate | Drug | Two 45 mg capsules once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects | Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency | between baseline and 24 weeks |
| Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects | Changes in markers of inflammation and immune activation by measuring monocyte activation soluble markers CD14 (sCD14), and soluble CD163 (sCD163), high sensitivity C reactive protein (hsCRP), D-dimer, vascular cell adhesion molecule-1 (VCAM), and intercellular adhesion molecule-1 (I-CAM) | between baseline and 24 Weeks |
| Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects | Changes in markers of inflammation and immune activation by measuring soluble tumor necrosis alpha receptor I and II (sTNFR-I and II), Interleukin-6 (IL-6), and interferon-gamma-inducible protein of 10 kDa (IP-10). | between baseline and 24 Weeks |
| Effect of Zinc on oxLDL in HIV-infected Subjects | Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks | between baseline and 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring Non-HDL cholesterol, high-density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), Cholesterol, Cholesterol - HDL Ratio, and Triglycerides. | between baseline and 24 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace A McComsey, MD, FIDSA | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Zinc Gluconate | Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. Zinc Gluconate: Two 45 mg capsules once daily |
| FG001 | Placebo | Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. Placebo: Two placebo capsules once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Zinc Gluconate | Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. Zinc Gluconate: Two 45 mg capsules once daily |
| BG001 | Placebo | Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. Placebo: Two placebo capsules once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects | Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | absolute change (μg/dL) | between baseline and 24 weeks |
|
6 months
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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 | Zinc Gluconate | Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. Zinc Gluconate: Two 45 mg capsules once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Injury, poisoning and procedural complications | Systematic Assessment | Death occurred secondary to drug overdose not related to study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal adhesions with intestinal torsion | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace McComsey | University Hospitals Cleveland Medical Center | 216-368-3731 | Grace.McComsey@uhhospitals.org |
Not provided
| 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 | Nov 19, 2024 | Apr 30, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2024 | May 19, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C030691 | gluconic acid |
Not provided
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This is a double-blind randomized placebo-controlled trial 2:1 Patients will be given zinc gluconate capsules at a dose of 90 mg elemental zinc daily or matching placebo for 24 weeks.
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Patients, study staff, and the study statistician will be blinded to treatment allocation (zinc gluconate or placebo capsules). The research staff as well as the principle investigator will remain blinded to treatment assignment.
| Drug |
Two placebo capsules once daily |
|
| Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio | between baseline and 24 Weeks |
| the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2) | between baseline and 24 Weeks |
| Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm) | between baseline and 24 Weeks |
| Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring body weight (lbs) | between baseline and 24 Weeks |
| Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV- | Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg) | between baseline and 24 Weeks |
| Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation were measured by measuring 10-year atherosclerotic cardiovascular disease (ASCVD), which is the probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years with higher scores indicating worse outcome | between baseline and 24 Weeks |
| Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects | Changes in markers of endothelial function including the Reactive Hyperemic Index and Augmentation Index Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia. A Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to baseline in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal, while a value of 1.67 or lower is considered abnormal. Higher values indicate better endothelial function. | between baseline and 24 Weeks |
| Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects | Changes in markers of Gut Integrity Markers including: intestinal fatty acid-binding protein (IFAB) and (1,3)-β-d-glucan (BDG) | between baseline and 24 Weeks |
| Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects | Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin. | between baseline and 24 Weeks |
| Death |
|
| Inability to swallow the pill |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| alcohol (current) | Count of Participants | Participants |
|
| smokers (current) | Count of Participants | Participants |
|
| CD4+ T-Cell Count | Median | Inter-Quartile Range | cells/mm³ |
|
| HIV RNA (<20 copies) | Count of Participants | Participants |
|
| Anti-Retroviral Treatment Duration | Median | Inter-Quartile Range | Months |
|
| Protease Inhibitor use | Count of Participants | Participants |
|
| Body Mass Index BMI | Median | Inter-Quartile Range | kg/m2 |
|
| Waist circumference | Median | Inter-Quartile Range | cm |
|
| Systolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
|
| Diastolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
|
| Non-High Density Lipoprotein non-HDL cholesterol | Median | Inter-Quartile Range | (mg/dL |
|
| High Density Lipoprotein | Median | Inter-Quartile Range | mg/dL |
|
| Low Density Lipoprotein LDL | Median | Inter-Quartile Range | mg/dl |
|
| Very Low Density Lipoprotein VLDL | Median | Inter-Quartile Range | mg/dl |
|
| Cholesterol | Median | Inter-Quartile Range | mg/dl |
|
| cholesterol/ high Density Lipoprotein Ratio | Median | Inter-Quartile Range | Ratio |
|
| Triglycerides | Median | Inter-Quartile Range | mg/dl |
|
| Insulin | Median | Inter-Quartile Range | mIU/mL |
|
| atherosclerotic cardiovascular risk 10 year ASCVD | probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years. | Median | Inter-Quartile Range | % |
|
| Presence of metabolic syndrome | Count of Participants | Participants |
|
| Endothelial Function: Reactive Hyperemic Index | Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia. A Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to the pulse wave amplitude (PWA) before the occlusion of the artery, in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal. Higher values indicate better endothelial function. | Median | Inter-Quartile Range | ratio |
|
| Endothelial Function: Augmentation Index | Median | Inter-Quartile Range | % |
|
| hsCRP | Median | Inter-Quartile Range | ng/mL |
|
| sCD14 | Median | Inter-Quartile Range | ng/mL |
|
| sCD163 | Median | Inter-Quartile Range | ng/mL |
|
| sTNFR-I | Median | Inter-Quartile Range | pg/mL |
|
| sTNFR-II | Median | Inter-Quartile Range | pg/mL |
|
| DDimer | Median | Inter-Quartile Range | ng/mL |
|
| oxLDL | Median | Inter-Quartile Range | U/L |
|
| IL-6 | Median | Inter-Quartile Range | pg/mL |
|
| VCAM | Median | Inter-Quartile Range | ng/mL |
|
| ICAM | Median | Inter-Quartile Range | ng/mL |
|
| IP-10 | Median | Inter-Quartile Range | pg/mL |
|
| LBP | Median | Inter-Quartile Range | μg/mL |
|
| IFAB | Median | Inter-Quartile Range | pg/mL |
|
| BDG | Median | Inter-Quartile Range | pg/mL |
|
| Zonulin | Median | Inter-Quartile Range | μg/mL |
|
| Zinc level | Median | Inter-Quartile Range | μg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects | Changes in markers of inflammation and immune activation by measuring monocyte activation soluble markers CD14 (sCD14), and soluble CD163 (sCD163), high sensitivity C reactive protein (hsCRP), D-dimer, vascular cell adhesion molecule-1 (VCAM), and intercellular adhesion molecule-1 (I-CAM) | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | ng/mL | between baseline and 24 Weeks |
|
|
|
|
| Primary | Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects | Changes in markers of inflammation and immune activation by measuring soluble tumor necrosis alpha receptor I and II (sTNFR-I and II), Interleukin-6 (IL-6), and interferon-gamma-inducible protein of 10 kDa (IP-10). | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | pg/mL | between baseline and 24 Weeks |
|
|
|
|
| Primary | Effect of Zinc on oxLDL in HIV-infected Subjects | Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | U/L | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring Non-HDL cholesterol, high-density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), Cholesterol, Cholesterol - HDL Ratio, and Triglycerides. | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | mg/dL | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | Ratio | between baseline and 24 Weeks |
|
|
|
|
| Secondary | the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2) | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | kg/m2 | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm) | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | cm | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation by measuring body weight (lbs) | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | lbs | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV- | Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg) | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | mmHg | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects | Changes in metabolic markers after zinc supplementation were measured by measuring 10-year atherosclerotic cardiovascular disease (ASCVD), which is the probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years with higher scores indicating worse outcome | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | percentage of 10-year ASCVD score | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects | Changes in markers of endothelial function including the Reactive Hyperemic Index and Augmentation Index Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia. A Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to baseline in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal, while a value of 1.67 or lower is considered abnormal. Higher values indicate better endothelial function. | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | (ratio) absolute change | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects | Changes in markers of Gut Integrity Markers including: intestinal fatty acid-binding protein (IFAB) and (1,3)-β-d-glucan (BDG) | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | pg/mL | between baseline and 24 Weeks |
|
|
|
|
| Secondary | Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects | Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin. | absolute changes for outcome measures over 24 weeks for each group | Posted | Median | Inter-Quartile Range | μg/mL | between baseline and 24 Weeks |
|
|
|
|
| 1 |
| 63 |
| 1 |
| 63 |
| 48 |
| 63 |
| EG001 | Placebo | Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. Placebo: Two placebo capsules once daily | 0 | 32 | 0 | 32 | 27 | 32 |
|
| Abcess post root canal | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| High Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Left groin hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Pain in right hip and Sciatica | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Peripheral Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Scrotal Abcess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Worsening of depression | Psychiatric disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | Systematic Assessment |
|
| High ALT and/or AST | Hepatobiliary disorders | Systematic Assessment |
|
| High Cholesterol | Metabolism and nutrition disorders | Systematic Assessment |
|
| High Creatine Kinase | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| High Creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Low Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Low Phosphorus | General disorders | Systematic Assessment |
|
| Low Sodium | General disorders | Systematic Assessment |
|
| High Sodium | General disorders | Systematic Assessment |
|
| High Alkaline Phosphatase | Hepatobiliary disorders | Systematic Assessment |
|
| High Bilirubin | Hepatobiliary disorders | Systematic Assessment |
|
| High Glucose | Metabolism and nutrition disorders | Systematic Assessment |
|
| High LDL | Metabolism and nutrition disorders | Systematic Assessment |
|
| High Triglycerides | Metabolism and nutrition disorders | Systematic Assessment |
|
| High Uric Acid | Metabolism and nutrition disorders | Systematic Assessment |
|
Not provided
Not provided
| sCD163 (ng/mL) |
|
| D-dimer (ng/mL) |
|
| VCAM (ng/mL) |
|
| ICAM (ng/mL) |
|
| effect of Zinc supplementation on ln(sCD14, ng/mL) | linear combination of coefficients | 0.08 | β coefficient | -0.08 | Standard Error of the Mean | 0.05 | 2-Sided | 95 | -0.18 | 0.01 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(sCD163, ng/mL) | linear combination of coefficients | 0.77 | β coefficient | -0.03 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -0.21 | 0.15 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(D-dimer, ng/mL) | linear combination of coefficients | 0.19 | β coefficient | 0.2 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.10 | 0.50 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(VCAM, ng/mL) | linear combination of coefficients | 0.10 | β coefficient | -0.19 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.41 | 0.04 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(ICAM, ng/mL) | linear combination of coefficients | 0.98 | β coefficient | 0.41 | Standard Error of the Mean | 20.19 | 2-Sided | 95 | -39.16 | 39.98 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| IL-6 (pg/mL) |
|
| IP-10 (pg/mL) |
|
| effect of Zinc supplementation on ln(sTNF-RII, pg/m) | linear combination of coefficients | 0.95 | β coefficient | -0.004 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.13 | 0.13 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(IL-6, pg/mL) | linear combination of coefficients | 0.73 | β coefficient | 0.07 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.30 | 0.43 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(IP-10, pg/mL) | linear combination of coefficients | 0.48 | β coefficient | 0.12 | Standard Error of the Mean | 0.18 | 2-Sided | 95 | -0.22 | 0.47 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| LDL (mg/dL) |
|
| VLDL (mg/dL) |
|
| Cholesterol (mg/dL) |
|
| Triglycerides (mg/dL) |
|
| effect of Zinc supplementation on ln(HDL (mg/dL)) | linear combination of coefficients | 0.18 | β coefficient | -0.08 | Standard Error of the Mean | 0.06 | 2-Sided | 95 | -0.19 | 0.04 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(LDL (mg/dL)) | linear combination of coefficients | 0.84 | β coefficient | -0.02 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -0.19 | 0.15 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(VLDL (mg/dL)) | linear combination of coefficients | 0.55 | β coefficient | 0.07 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.15 | 0.29 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(Cholesterol (mg/dl)) | linear combination of coefficients | 0.78 | β coefficient | -0.01 | Standard Error of the Mean | 0.05 | 2-Sided | 95 | -0.11 | 0.09 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(Triglycerides (mg/dL)) | linear combination of coefficients | 0.58 | β coefficient | 0.07 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.17 | 0.31 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on Metabolic Syndrome | linear combination of coefficients | 0.35 | β coefficient | -0.44 | Standard Error of the Mean | 0.47 | 2-Sided | 95 | -1.36 | 0.48 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on Diastolic blood pressure (mmHg) | linear combination of coeff | 0.42 | β coefficient | -1.68 | Standard Error of the Mean | 2.06 | 2-Sided | 95 | -5.71 | 2.36 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on Augmentation Index | linear combination of coefficients | 0.81 | β coefficient | 0.59 | Standard Error of the Mean | 2.43 | 2-Sided | 95 | -4.19 | 5.36 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(BDG (pg/mL)) | linear combination of coefficients | 0.24 | β coefficient | 0.18 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.12 | 0.47 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |
| effect of Zinc supplementation on ln(Zonulin (ng/mL) | linear combination of coefficients | 0.49 | β coefficient | 0.09 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.16 | 0.34 | Other | Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers. |