Trial Outcomes & Findings for Zinc Effect on Inflammation and Cardiovascular Risk in HIV (NCT NCT05085834)
NCT ID: NCT05085834
Last Updated: 2025-06-12
Results Overview
Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
95 participants
Primary outcome timeframe
between baseline and 24 weeks
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
Zinc Gluconate
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Zinc Gluconate: Two 45 mg capsules once daily
|
Placebo
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Placebo: Two placebo capsules once daily
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
32
|
|
Overall Study
COMPLETED
|
47
|
29
|
|
Overall Study
NOT COMPLETED
|
16
|
3
|
Reasons for withdrawal
| Measure |
Zinc Gluconate
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Zinc Gluconate: Two 45 mg capsules once daily
|
Placebo
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Placebo: Two placebo capsules once daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
2
|
|
Overall Study
Adverse Event
|
6
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Inability to swallow the pill
|
0
|
1
|
Baseline Characteristics
Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Baseline characteristics by cohort
| Measure |
Zinc Gluconate
n=63 Participants
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Zinc Gluconate: Two 45 mg capsules once daily
|
Placebo
n=32 Participants
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Placebo: Two placebo capsules once daily
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.42 years
n=5 Participants
|
53.29 years
n=7 Participants
|
52.42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
alcohol (current)
|
45 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
smokers (current)
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
CD4+ T-Cell Count
|
747.00 cells/mm³
n=5 Participants
|
668.00 cells/mm³
n=7 Participants
|
722.00 cells/mm³
n=5 Participants
|
|
HIV RNA (<20 copies)
|
51 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Anti-Retroviral Treatment Duration
|
178.76 Months
n=5 Participants
|
167.86 Months
n=7 Participants
|
171.86 Months
n=5 Participants
|
|
Protease Inhibitor use
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Body Mass Index BMI
|
28.34 kg/m2
n=5 Participants
|
27.45 kg/m2
n=7 Participants
|
28.08 kg/m2
n=5 Participants
|
|
Waist circumference
|
96.67 cm
n=5 Participants
|
97.83 cm
n=7 Participants
|
97.00 cm
n=5 Participants
|
|
Systolic Blood Pressure
|
125 mmHg
n=5 Participants
|
129 mmHg
n=7 Participants
|
126 mmHg
n=5 Participants
|
|
Diastolic Blood Pressure
|
80 mmHg
n=5 Participants
|
82 mmHg
n=7 Participants
|
81 mmHg
n=5 Participants
|
|
Non-High Density Lipoprotein non-HDL cholesterol
|
115.30 (mg/dL
n=5 Participants
|
115.50 (mg/dL
n=7 Participants
|
115.30 (mg/dL
n=5 Participants
|
|
High Density Lipoprotein
|
45.40 mg/dL
n=5 Participants
|
48.15 mg/dL
n=7 Participants
|
47.00 mg/dL
n=5 Participants
|
|
Low Density Lipoprotein LDL
|
96 mg/dl
n=5 Participants
|
89 mg/dl
n=7 Participants
|
96 mg/dl
n=5 Participants
|
|
Very Low Density Lipoprotein VLDL
|
22 mg/dl
n=5 Participants
|
20 mg/dl
n=7 Participants
|
21 mg/dl
n=5 Participants
|
|
Cholesterol
|
171 mg/dl
n=5 Participants
|
165.5 mg/dl
n=7 Participants
|
169 mg/dl
n=5 Participants
|
|
cholesterol/ high Density Lipoprotein Ratio
|
3.5 Ratio
n=5 Participants
|
3.2 Ratio
n=7 Participants
|
3.4 Ratio
n=5 Participants
|
|
Triglycerides
|
108 mg/dl
n=5 Participants
|
103 mg/dl
n=7 Participants
|
105 mg/dl
n=5 Participants
|
|
Insulin
|
10 mIU/mL
n=5 Participants
|
11.5 mIU/mL
n=7 Participants
|
10.5 mIU/mL
n=5 Participants
|
|
atherosclerotic cardiovascular risk 10 year ASCVD
|
6.1 %
n=5 Participants
|
6.7 %
n=7 Participants
|
6.5 %
n=5 Participants
|
|
Presence of metabolic syndrome
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Endothelial Function: Reactive Hyperemic Index
|
1.91 ratio
n=5 Participants
|
1.89 ratio
n=7 Participants
|
1.9 ratio
n=5 Participants
|
|
Endothelial Function: Augmentation Index
|
7.5 %
n=5 Participants
|
11 %
n=7 Participants
|
10 %
n=5 Participants
|
|
hsCRP
|
2240.00 ng/mL
n=5 Participants
|
1998.85 ng/mL
n=7 Participants
|
2202.14 ng/mL
n=5 Participants
|
|
sCD14
|
1671.20 ng/mL
n=5 Participants
|
1727.05 ng/mL
n=7 Participants
|
1681.63 ng/mL
n=5 Participants
|
|
sCD163
|
543.40 ng/mL
n=5 Participants
|
593.61 ng/mL
n=7 Participants
|
568.55 ng/mL
n=5 Participants
|
|
sTNFR-I
|
1036.85 pg/mL
n=5 Participants
|
977.39 pg/mL
n=7 Participants
|
1006.42 pg/mL
n=5 Participants
|
|
sTNFR-II
|
2162.27 pg/mL
n=5 Participants
|
2253.23 pg/mL
n=7 Participants
|
2234.54 pg/mL
n=5 Participants
|
|
DDimer
|
558.43 ng/mL
n=5 Participants
|
520.93 ng/mL
n=7 Participants
|
536.22 ng/mL
n=5 Participants
|
|
oxLDL
|
51731.12 U/L
n=5 Participants
|
47606.57 U/L
n=7 Participants
|
50145.48 U/L
n=5 Participants
|
|
IL-6
|
2.11 pg/mL
n=5 Participants
|
1.89 pg/mL
n=7 Participants
|
1.94 pg/mL
n=5 Participants
|
|
VCAM
|
758.04 ng/mL
n=5 Participants
|
857.01 ng/mL
n=7 Participants
|
783.99 ng/mL
n=5 Participants
|
|
ICAM
|
244.28 ng/mL
n=5 Participants
|
250.13 ng/mL
n=7 Participants
|
247.37 ng/mL
n=5 Participants
|
|
IP-10
|
130.52 pg/mL
n=5 Participants
|
134.70 pg/mL
n=7 Participants
|
134.48 pg/mL
n=5 Participants
|
|
LBP
|
16.6 μg/mL
n=5 Participants
|
16.44 μg/mL
n=7 Participants
|
16.6 μg/mL
n=5 Participants
|
|
IFAB
|
1826.49 pg/mL
n=5 Participants
|
1616.94 pg/mL
n=7 Participants
|
1730.93 pg/mL
n=5 Participants
|
|
BDG
|
98.46 pg/mL
n=5 Participants
|
122.51 pg/mL
n=7 Participants
|
106.08 pg/mL
n=5 Participants
|
|
Zonulin
|
1020 μg/mL
n=5 Participants
|
1040 μg/mL
n=7 Participants
|
1030 μg/mL
n=5 Participants
|
|
Zinc level
|
70 μg/dL
n=5 Participants
|
69 μg/dL
n=7 Participants
|
69.8 μg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: between baseline and 24 weeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects
|
8.60 absolute change (μg/dL)
Interval 1.65 to 20.0
|
33.50 absolute change (μg/dL)
Interval 14.0 to 62.7
|
PRIMARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
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)
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
hsCRP (ng/mL)
|
-22.86 ng/mL
Interval -689.27 to 1744.48
|
1.33 ng/mL
Interval -602.56 to 1174.87
|
|
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
sCD14 (ng/mL)
|
101.71 ng/mL
Interval -90.5 to 243.2
|
-56.31 ng/mL
Interval -263.24 to 134.19
|
|
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
sCD163 (ng/mL)
|
-50.11 ng/mL
Interval -153.06 to 89.8
|
43.69 ng/mL
Interval -102.27 to 126.91
|
|
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
D-dimer (ng/mL)
|
-149.05 ng/mL
Interval -294.46 to 58.72
|
-45.85 ng/mL
Interval -295.57 to 142.43
|
|
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
VCAM (ng/mL)
|
66.69 ng/mL
Interval -2.65 to 187.38
|
49.53 ng/mL
Interval -55.61 to 170.15
|
|
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
ICAM (ng/mL)
|
-2.03 ng/mL
Interval -28.37 to 22.3
|
2.35 ng/mL
Interval -29.19 to 42.46
|
PRIMARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
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).
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects
sTNF-RI (pg/mL)
|
-25.08 pg/mL
Interval -209.51 to 186.66
|
1.27 pg/mL
Interval -236.8 to 168.27
|
|
Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects
sTNF-RII (pg/mL)
|
-121.65 pg/mL
Interval -457.93 to 467.29
|
99.33 pg/mL
Interval -484.31 to 477.72
|
|
Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects
IL-6 (pg/mL)
|
-0.47 pg/mL
Interval -0.85 to 0.61
|
-0.02 pg/mL
Interval -0.88 to 0.72
|
|
Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects
IP-10 (pg/mL)
|
0.23 pg/mL
Interval -44.28 to 29.08
|
-9.99 pg/mL
Interval -31.65 to 20.27
|
PRIMARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc on oxLDL in HIV-infected Subjects
|
20833.33 U/L
Interval 2397.72 to 61644.46
|
8639.79 U/L
Interval -1716.35 to 43693.14
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
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.
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
Non-HDL cholesterol (mg/dL)
|
3.10 mg/dL
Interval -28.2 to 26.5
|
1.35 mg/dL
Interval -12.3 to 10.85
|
|
Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
HDL (mg/dL)
|
-1.70 mg/dL
Interval -4.6 to 1.4
|
-2.45 mg/dL
Interval -8.45 to 1.25
|
|
Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
LDL (mg/dL)
|
6.00 mg/dL
Interval -28.0 to 16.0
|
-1.50 mg/dL
Interval -19.5 to 11.5
|
|
Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
VLDL (mg/dL)
|
0.50 mg/dL
Interval -6.0 to 3.5
|
2.00 mg/dL
Interval -2.0 to 6.0
|
|
Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
Cholesterol (mg/dL)
|
2.00 mg/dL
Interval -25.0 to 27.0
|
-3.50 mg/dL
Interval -23.5 to 12.0
|
|
Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
Triglycerides (mg/dL)
|
2.00 mg/dL
Interval -29.0 to 12.0
|
7.00 mg/dL
Interval -12.5 to 34.5
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects
|
0.10 Ratio
Interval -0.2 to 0.4
|
0.10 Ratio
Interval -0.1 to 0.45
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2)
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects
|
0.28 kg/m2
Interval -0.52 to 1.16
|
0.10 kg/m2
Interval -0.58 to 0.95
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm)
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects
|
0.50 cm
Interval -2.53 to 2.5
|
1.67 cm
Interval -2.67 to 3.0
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in metabolic markers after zinc supplementation by measuring body weight (lbs)
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects
|
2.20 lbs
Interval -3.5 to 7.6
|
0.00 lbs
Interval -4.0 to 4.4
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-
Systolic Blood Pressure (mmHg)
|
6.00 mmHg
Interval -4.0 to 12.0
|
0.00 mmHg
Interval -9.0 to 9.0
|
|
Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-
Diastolic Blood Pressure (mmHg)
|
3.00 mmHg
Interval -5.0 to 6.0
|
0.00 mmHg
Interval -5.0 to 5.0
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
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
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects
|
0.40 percentage of 10-year ASCVD score
Interval -1.1 to 2.0
|
0.00 percentage of 10-year ASCVD score
Interval -1.35 to 1.55
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
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.
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects
Reactive Hyperemic Index
|
-0.34 (ratio) absolute change
Interval -0.77 to 0.16
|
-0.18 (ratio) absolute change
Interval -0.6 to 0.23
|
|
Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects
Augmentation Index
|
0.00 (ratio) absolute change
Interval -8.0 to 5.5
|
-1.00 (ratio) absolute change
Interval -7.0 to 6.0
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in markers of Gut Integrity Markers including: intestinal fatty acid-binding protein (IFAB) and (1,3)-β-d-glucan (BDG)
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects
BDG (pg/mL)
|
-28.19 pg/mL
Interval -100.43 to 4.02
|
8.36 pg/mL
Interval -63.26 to 76.12
|
|
Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects
IFAB (pg/mL)
|
100.82 pg/mL
Interval -747.0 to 953.32
|
58.89 pg/mL
Interval -1049.29 to 654.96
|
SECONDARY outcome
Timeframe: between baseline and 24 WeeksPopulation: absolute changes for outcome measures over 24 weeks for each group
Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin.
Outcome measures
| Measure |
Placebo
n=32 Participants
participants assigned to the placebo group
|
Zinc 90 mg
n=63 Participants
participants assigned to the Zinc group
|
|---|---|---|
|
Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects
LBP (μg/mL)
|
0.47 μg/mL
Interval -4.8 to 8.35
|
0.72 μg/mL
Interval -4.52 to 6.9
|
|
Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects
Zonulin (μg/mL)
|
78.2 μg/mL
Interval -138.0 to 506.86
|
270.54 μg/mL
Interval 59.36 to 600.45
|
Adverse Events
Zinc Gluconate
Serious events: 1 serious events
Other events: 48 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zinc Gluconate
n=63 participants at risk
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Zinc Gluconate: Two 45 mg capsules once daily
|
Placebo
n=32 participants at risk
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Placebo: Two placebo capsules once daily
|
|---|---|---|
|
Injury, poisoning and procedural complications
Death
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
Other adverse events
| Measure |
Zinc Gluconate
n=63 participants at risk
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Zinc Gluconate: Two 45 mg capsules once daily
|
Placebo
n=32 participants at risk
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Placebo: Two placebo capsules once daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesions with intestinal torsion
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Gastrointestinal disorders
Abcess post root canal
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Gastrointestinal disorders
Bloating
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Nervous system disorders
Dizziness
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Cardiac disorders
High Blood Pressure
|
0.00%
0/63 • 6 months
|
3.1%
1/32 • 6 months
|
|
Cardiac disorders
Chest Pain
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Gastrointestinal disorders
Left groin hernia
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in right hip and Sciatica
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Nervous system disorders
Peripheral Neuropathy
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Skin and subcutaneous tissue disorders
Scrotal Abcess
|
0.00%
0/63 • 6 months
|
3.1%
1/32 • 6 months
|
|
Psychiatric disorders
Worsening of depression
|
1.6%
1/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Gastrointestinal disorders
nausea
|
12.7%
8/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Gastrointestinal disorders
Stomach Pain
|
3.2%
2/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Hepatobiliary disorders
High ALT and/or AST
|
12.7%
8/63 • 6 months
|
3.1%
1/32 • 6 months
|
|
Metabolism and nutrition disorders
High Cholesterol
|
22.2%
14/63 • 6 months
|
40.6%
13/32 • 6 months
|
|
Musculoskeletal and connective tissue disorders
High Creatine Kinase
|
9.5%
6/63 • 6 months
|
3.1%
1/32 • 6 months
|
|
Renal and urinary disorders
High Creatinine
|
30.2%
19/63 • 6 months
|
53.1%
17/32 • 6 months
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
3.2%
2/63 • 6 months
|
3.1%
1/32 • 6 months
|
|
General disorders
Low Phosphorus
|
1.6%
1/63 • 6 months
|
6.2%
2/32 • 6 months
|
|
General disorders
Low Sodium
|
3.2%
2/63 • 6 months
|
3.1%
1/32 • 6 months
|
|
General disorders
High Sodium
|
0.00%
0/63 • 6 months
|
3.1%
1/32 • 6 months
|
|
Hepatobiliary disorders
High Alkaline Phosphatase
|
3.2%
2/63 • 6 months
|
0.00%
0/32 • 6 months
|
|
Hepatobiliary disorders
High Bilirubin
|
3.2%
2/63 • 6 months
|
15.6%
5/32 • 6 months
|
|
Metabolism and nutrition disorders
High Glucose
|
47.6%
30/63 • 6 months
|
53.1%
17/32 • 6 months
|
|
Metabolism and nutrition disorders
High LDL
|
15.9%
10/63 • 6 months
|
25.0%
8/32 • 6 months
|
|
Metabolism and nutrition disorders
High Triglycerides
|
39.7%
25/63 • 6 months
|
34.4%
11/32 • 6 months
|
|
Metabolism and nutrition disorders
High Uric Acid
|
17.5%
11/63 • 6 months
|
21.9%
7/32 • 6 months
|
Additional Information
Grace McComsey
University Hospitals Cleveland Medical Center
Phone: 216-368-3731
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place