Trial Outcomes & Findings for Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children (NCT NCT01062009)
NCT ID: NCT01062009
Last Updated: 2019-08-20
Results Overview
Plasma Zinc levels were measured daily during the seven day study period in each group.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
7 days
Results posted on
2019-08-20
Participant Flow
One patient was enrolled but withdrawn by PI due to insufficient intravenous access to obtain study labs
Participant milestones
| Measure |
Control Group
No intervention
|
Low Dose Group
250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
Medium Dose Group
500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
High Dose Group
750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children
Baseline characteristics by cohort
| Measure |
Control Group
n=6 Participants
No intervention
|
Low Dose Group
n=6 Participants
250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
Medium Dose Group
n=6 Participants
500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
High Dose Group
n=6 Participants
750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
1.5 years
n=5 Participants
|
1.8 years
n=7 Participants
|
5.3 years
n=5 Participants
|
2.6 years
n=4 Participants
|
1.9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Pediatric Risk of Mortality (PRISM) III
|
12 units on a scale
n=5 Participants
|
8 units on a scale
n=7 Participants
|
12 units on a scale
n=5 Participants
|
9 units on a scale
n=4 Participants
|
9 units on a scale
n=21 Participants
|
|
Pediatric Index of Mortality (PIM)
|
3.4 percentage mortality risk
n=5 Participants
|
6.0 percentage mortality risk
n=7 Participants
|
7.0 percentage mortality risk
n=5 Participants
|
5.2 percentage mortality risk
n=4 Participants
|
5.9 percentage mortality risk
n=21 Participants
|
|
Pediatric Logistic Organ Dysfunction (PELOD )
|
11 units on a scale
n=5 Participants
|
11 units on a scale
n=7 Participants
|
20 units on a scale
n=5 Participants
|
21 units on a scale
n=4 Participants
|
11 units on a scale
n=21 Participants
|
|
Number of patients with >= 2 organs failed
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
13 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 daysPlasma Zinc levels were measured daily during the seven day study period in each group.
Outcome measures
| Measure |
Control Group
n=6 Participants
No intervention
|
Low Dose Group
n=6 Participants
250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
Medium Dose Group
n=6 Participants
500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
High Dose Group
n=6 Participants
750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
|---|---|---|---|---|
|
Plasma Zinc Concentration Over Time
Day 1
|
51.2 mcg/dL
Standard Deviation 14.8
|
36.4 mcg/dL
Standard Deviation 8.8
|
37.7 mcg/dL
Standard Deviation 25.2
|
43.4 mcg/dL
Standard Deviation 9.7
|
|
Plasma Zinc Concentration Over Time
Day 2
|
63.0 mcg/dL
Standard Deviation 10.1
|
42.1 mcg/dL
Standard Deviation 15.4
|
46.3 mcg/dL
Standard Deviation 29.1
|
71.5 mcg/dL
Standard Deviation 34.6
|
|
Plasma Zinc Concentration Over Time
Day 3
|
60.3 mcg/dL
Standard Deviation 10.7
|
47.4 mcg/dL
Standard Deviation 17.8
|
52.3 mcg/dL
Standard Deviation 10.9
|
68.2 mcg/dL
Standard Deviation 33.4
|
|
Plasma Zinc Concentration Over Time
Day 4
|
59.5 mcg/dL
Standard Deviation 4.3
|
54.4 mcg/dL
Standard Deviation 17.6
|
63.3 mcg/dL
Standard Deviation 18.9
|
101.9 mcg/dL
Standard Deviation 33.4
|
|
Plasma Zinc Concentration Over Time
Day 5
|
57.3 mcg/dL
Standard Deviation 5.1
|
58.9 mcg/dL
Standard Deviation 12.9
|
66.8 mcg/dL
Standard Deviation 20.0
|
71.0 mcg/dL
Standard Deviation 16.9
|
|
Plasma Zinc Concentration Over Time
Day 6
|
56.8 mcg/dL
Standard Deviation 7.3
|
62.6 mcg/dL
Standard Deviation 15.7
|
66.0 mcg/dL
Standard Deviation 16.8
|
114.0 mcg/dL
Standard Deviation 43.7
|
|
Plasma Zinc Concentration Over Time
Day 7
|
58.7 mcg/dL
Standard Deviation 4.9
|
67.1 mcg/dL
Standard Deviation 12.2
|
67.6 mcg/dL
Standard Deviation 10.8
|
93.3 mcg/dL
Standard Deviation 8.7
|
PRIMARY outcome
Timeframe: 7 daysBecause of reports of fever in patients wiht zinc overdoses, we monitored patients for new fever while on supplementation
Outcome measures
| Measure |
Control Group
n=6 Participants
No intervention
|
Low Dose Group
n=6 Participants
250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
Medium Dose Group
n=6 Participants
500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
High Dose Group
n=6 Participants
750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
|---|---|---|---|---|
|
New Fever
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 daysPatients were assigned a score based on glucose range to take into account the degree of hyperglycemia as well as the need for insulin over the course of the 7 day study period. This score is an ordinal scale ranging from 1 to 5, with a score of 1 indicating no hyperglycemia, and 5 indicating severe hyperglycemia despite insulin administration.
Outcome measures
| Measure |
Control Group
n=6 Participants
No intervention
|
Low Dose Group
n=6 Participants
250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
Medium Dose Group
n=6 Participants
500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
High Dose Group
n=6 Participants
750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
|---|---|---|---|---|
|
Glucose Homeostasis
Day 1
|
4 units on a scale
Interval 3.25 to 4.0
|
3.5 units on a scale
Interval 3.0 to 4.0
|
4 units on a scale
Interval 2.5 to 4.0
|
2.5 units on a scale
Interval 2.0 to 3.75
|
|
Glucose Homeostasis
Day 2
|
3.5 units on a scale
Interval 2.25 to 4.0
|
3.5 units on a scale
Interval 2.25 to 4.0
|
4 units on a scale
Interval 4.0 to 4.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Glucose Homeostasis
Day 3
|
3.5 units on a scale
Interval 2.25 to 4.0
|
3.5 units on a scale
Interval 2.25 to 4.0
|
4 units on a scale
Interval 3.25 to 4.0
|
2 units on a scale
Interval 2.0 to 2.75
|
|
Glucose Homeostasis
Day 4
|
3 units on a scale
Interval 2.0 to 3.0
|
4 units on a scale
Interval 4.0 to 4.0
|
4 units on a scale
Interval 4.0 to 4.0
|
2 units on a scale
Interval 2.0 to 2.75
|
|
Glucose Homeostasis
Day 5
|
3 units on a scale
Interval 2.0 to 3.0
|
4 units on a scale
Interval 3.25 to 4.0
|
4 units on a scale
Interval 3.25 to 4.0
|
2 units on a scale
Interval 2.0 to 3.5
|
|
Glucose Homeostasis
Day 6
|
4 units on a scale
Interval 2.0 to 4.0
|
3.5 units on a scale
Interval 2.25 to 4.0
|
4 units on a scale
Interval 2.5 to 4.0
|
3 units on a scale
Interval 3.0 to 4.0
|
|
Glucose Homeostasis
Day 7
|
4 units on a scale
Interval 2.5 to 4.0
|
2.5 units on a scale
Interval 2.0 to 3.75
|
3 units on a scale
Interval 3.0 to 3.0
|
2 units on a scale
Interval 1.75 to 2.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=6 participants at risk
No intervention
|
Low Dose Group
n=6 participants at risk
250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
Medium Dose Group
n=6 participants at risk
500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
High Dose Group
n=6 participants at risk
750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days
Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Refractory hypoxemia
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
Other adverse events
Adverse event data not reported
Additional Information
Natalie Cvijanovich, MD
UCSF Benioff Childrens Hospital Oakland
Phone: 510-428-3784
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place