Trial Outcomes & Findings for Oral Zinc for the Treatment of Acute Diarrhea in US Children (NCT NCT01198587)
NCT ID: NCT01198587
Last Updated: 2018-08-22
Results Overview
Patients symptoms will be assessed to identify the duration of diarrhea between zinc and placebo groups before it becomes chronic diarrhea which by definition lasts longer than 14 days. Outcome of all patients in study will be assessed at study conclusion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
14 days
Results posted on
2018-08-22
Participant Flow
Patient were screened from the emergency department to identify patient meeting study enrollment criteria
Participant milestones
| Measure |
Outpatient Zinc Sulfate
Outpatients with diarrhea will be randomized to either zinc or placebo to assess the effect on duration of diarrhea.
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc or placebo, duration of hospitalization will be assessed.
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
Patient discharged randomized to Placebo Oral Capsule
|
Inpatient Placebo
Hospitalized patients randomized to Placebo oral capsule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
5
|
30
|
5
|
|
Overall Study
COMPLETED
|
23
|
5
|
21
|
5
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
9
|
0
|
Reasons for withdrawal
| Measure |
Outpatient Zinc Sulfate
Outpatients with diarrhea will be randomized to either zinc or placebo to assess the effect on duration of diarrhea.
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc or placebo, duration of hospitalization will be assessed.
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
Patient discharged randomized to Placebo Oral Capsule
|
Inpatient Placebo
Hospitalized patients randomized to Placebo oral capsule
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
0
|
9
|
0
|
Baseline Characteristics
Oral Zinc for the Treatment of Acute Diarrhea in US Children
Baseline characteristics by cohort
| Measure |
Outpatient Zinc Sulfate
n=31 Participants
Outpatients with diarrhea will be randomized to Zinc Sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
n=5 Participants
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc Sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
n=30 Participants
Outpatients with diarrhea will be randomized to Placebo oral capsule
|
Inpatient Placebo
n=5 Participants
Patients admitted to the hospital with diarrhea and dehydration will be randomized to Placebo oral capsule
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
2.3 years
n=5 Participants
|
2.9 years
n=7 Participants
|
2 years
n=5 Participants
|
3.6 years
n=4 Participants
|
2.7 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The study failed to enroll sufficient inpatients due to the low hospitalization rate in the US for children who are otherwise healthy with diarrhea All patients were analyzed separately by arm and then again together for overall severity of diarrhea
Patients symptoms will be assessed to identify the duration of diarrhea between zinc and placebo groups before it becomes chronic diarrhea which by definition lasts longer than 14 days. Outcome of all patients in study will be assessed at study conclusion.
Outcome measures
| Measure |
Outpatient Zinc Sulfate
n=23 Participants
Outpatients with diarrhea will be randomized to zinc sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
n=5 Participants
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate.
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
n=21 Participants
Outpatients with diarrhea will be randomized to placebo oral capsule
|
Inpatient Placebo
n=5 Participants
Hospitalized patients with diarrhea and dehydration will be randomized to placebo oral capsule
|
|---|---|---|---|---|
|
Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.
|
73 Hours
Standard Deviation 77.8
|
72 Hours
Standard Deviation 78.7
|
48 Hours
Standard Deviation 52.6
|
76.8 Hours
Standard Deviation 81.2
|
SECONDARY outcome
Timeframe: over the 14 day symptom monitoring periodOutcome measures
| Measure |
Outpatient Zinc Sulfate
n=23 Participants
Outpatients with diarrhea will be randomized to zinc sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
n=5 Participants
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate.
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
n=21 Participants
Outpatients with diarrhea will be randomized to placebo oral capsule
|
Inpatient Placebo
n=5 Participants
Hospitalized patients with diarrhea and dehydration will be randomized to placebo oral capsule
|
|---|---|---|---|---|
|
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents
Work Days Lost
|
93.5 Hours
Standard Deviation 9.3
|
34 Hours
Standard Deviation 27.5
|
93.5 Hours
Standard Deviation 9.6
|
21 Hours
Standard Deviation 26
|
|
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents
Daycare Days Lost
|
95.3 Hours
Standard Deviation 9.3
|
29.5 Hours
Standard Deviation 27.5
|
93.7 Hours
Standard Deviation 9.6
|
29.5 Hours
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: agreement over the 14 day follow up periodPopulation: All patients enrolled in the study
Kappa inter-rater reliability measurement was done to analyze the agreement between the phone call data with parents reporting the number of episodes of diarrhea per day were compared to the written symptom charts where parents recorded the number of episodes of diarrhea per day. The inter-rater reliability ranges from 0 to 1 with scores of 0-0.2 = poor agreement, 0.2-0.4 = fair agreement, 0.4-0.6 = moderate agreement, 0.6-0.8 = good agreement and 0.8-1 = very good agreement
Outcome measures
| Measure |
Outpatient Zinc Sulfate
n=23 Participants
Outpatients with diarrhea will be randomized to zinc sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
n=5 Participants
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate.
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
n=21 Participants
Outpatients with diarrhea will be randomized to placebo oral capsule
|
Inpatient Placebo
n=5 Participants
Hospitalized patients with diarrhea and dehydration will be randomized to placebo oral capsule
|
|---|---|---|---|---|
|
Assess Parent Reporting Reliability Comparing Survey Responses to Phone Interview.
|
0.84 kappa statistic
|
0.84 kappa statistic
|
0.84 kappa statistic
|
0.84 kappa statistic
|
Adverse Events
Outpatient Zinc Sulfate
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Inpatient Zinc Sulfate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outpatient Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Inpatient Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Outpatient Zinc Sulfate
n=23 participants at risk
Outpatients with diarrhea will be randomized to zinc sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
n=5 participants at risk
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
n=21 participants at risk
Outpatients with diarrhea will be randomized to placebo oral capsule
|
Inpatient Placebo
n=5 participants at risk
Patients admitted to the hospital with diarrhea and dehydration will be randomized to placebo oral capsule
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Surgical abdomen
|
0.00%
0/23 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/5 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/21 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/5 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
|
Gastrointestinal disorders
Hospitalization after starting the study protocol within 14 days
|
4.3%
1/23 • Number of events 1 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/5 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/21 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/5 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
Other adverse events
| Measure |
Outpatient Zinc Sulfate
n=23 participants at risk
Outpatients with diarrhea will be randomized to zinc sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Inpatient Zinc Sulfate
n=5 participants at risk
Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate
Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
|
Outpatient Placebo
n=21 participants at risk
Outpatients with diarrhea will be randomized to placebo oral capsule
|
Inpatient Placebo
n=5 participants at risk
Patients admitted to the hospital with diarrhea and dehydration will be randomized to placebo oral capsule
|
|---|---|---|---|---|
|
Gastrointestinal disorders
discontinued due to vomiting/tast
|
8.7%
2/23 • Number of events 4 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/5 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
9.5%
2/21 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
0.00%
0/5 • Data on adverse events were collected for each patient for their 28 day study period. The trial was conducted from November 1 2010 to May 25 2014. The primary completion date of the trial was May 15th 2014 and the study completion date was May 25th 2014.
|
Additional Information
Michelle Niescierenko MD MPH
Boston Children's Hospital
Phone: 617-919-4121
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place