Trial Outcomes & Findings for Zinc Supplementation and Cardiovascular Risk in HIV (NCT NCT02856269)
NCT ID: NCT02856269
Last Updated: 2022-02-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Baseline and 16 Weeks
Results posted on
2022-02-11
Participant Flow
Participants were recruited based on physician referral at University Hospitals Cleveland Medical Center between September 2016 and February 2018.
Of 118 patients screened, 52 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zinc Supplementation and Cardiovascular Risk in HIV
Baseline characteristics by cohort
| Measure |
45 mg Daily
n=25 Participants
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.
|
90 mg Daily
n=27 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
47 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Zinc levels
|
74.00 μg/dL
n=5 Participants
|
73.00 μg/dL
n=7 Participants
|
73 μg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 WeeksPopulation: Intent to treat population (all participants assigned to zinc 45 mmg or zinc 90 mg).
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.
Outcome measures
| Measure |
45 mg Daily
n=25 Participants
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.
|
90 mg Daily
n=27 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
sCD14
|
15 Participants
|
15 Participants
|
|
Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
sTNF-RI
|
14 Participants
|
15 Participants
|
|
Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
hs-CRP
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 16 WeeksAfter treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels \>75 μg/dL.
Outcome measures
| Measure |
45 mg Daily
n=25 Participants
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.
|
90 mg Daily
n=27 Participants
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.
|
|---|---|---|
|
Percentage of Participants That Reached the Zinc Sufficient Level After Treatment
|
88 percentage of participants
|
96 percentage of participants
|
Adverse Events
45 mg Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
90 mg Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
45 mg Daily
n=25 participants at risk
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.
|
90 mg Daily
n=27 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • 16 Weeks
At entry, weeks 4,10, and 16, All-Cause Mortality and Serious Adverse Events were assessed.
|
3.7%
1/27 • Number of events 1 • 16 Weeks
At entry, weeks 4,10, and 16, All-Cause Mortality and Serious Adverse Events were assessed.
|
|
Gastrointestinal disorders
Abdominal cramps
|
0.00%
0/25 • 16 Weeks
At entry, weeks 4,10, and 16, All-Cause Mortality and Serious Adverse Events were assessed.
|
3.7%
1/27 • Number of events 1 • 16 Weeks
At entry, weeks 4,10, and 16, All-Cause Mortality and Serious Adverse Events were assessed.
|
Additional Information
Dr. Grace McComsey
University Hospitals Cleveland Medical Center
Phone: 216-8442739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place