Trial · NCT01198587

Oral Zinc for the Treatment of Acute Diarrhea in US Children

NCT01198587, Not applicable, Completed, Boston Children's Hospital; results first posted 2018-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oral Zinc for the Treatment of Acute Diarrhea in US Children. Trials, record NCT01198587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01198587

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Oral Zinc for the Treatment of Acute Diarrhea in US Children
NCT number: NCT01198587
Status: Completed
Phases: Not applicable
Enrollment: 71 participants, actual
Lead sponsor: Boston Children's Hospital
Conditions: Diarrhea, Gastroenteritis
Interventions: Zinc Sulfate, Placebo oral capsule
First posted: 2010-09-10
Last updated: 2018-08-22
Results first posted: 2018-08-22

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.	14 days	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.
Secondary	Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	over the 14 day symptom monitoring period
Secondary	Assess Parent Reporting Reliability Comparing Survey Responses to Phone Interview.	agreement over the 14 day follow up period	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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.	14 days	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	Hours	MEAN
SECONDARY	Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	over the 14 day symptom monitoring period		Hours	MEAN
SECONDARY	Assess Parent Reporting Reliability Comparing Survey Responses to Phone Interview.	agreement over the 14 day follow up period	All patients enrolled in the study	kappa statistic	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.	Outpatient Zinc Sulfate		73	Standard Deviation 77.8	Hours
Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.	Inpatient Zinc Sulfate		72	Standard Deviation 78.7	Hours
Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.	Outpatient Placebo		48	Standard Deviation 52.6	Hours
Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.	Inpatient Placebo		76.8	Standard Deviation 81.2	Hours
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	Outpatient Zinc Sulfate	Daycare Days Lost	95.3	Standard Deviation 9.3	Hours
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	Inpatient Zinc Sulfate	Daycare Days Lost	29.5	Standard Deviation 27.5	Hours
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	Outpatient Placebo	Daycare Days Lost	93.7	Standard Deviation 9.6	Hours
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	Inpatient Placebo	Daycare Days Lost	29.5	Standard Deviation 27.5	Hours
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	Outpatient Zinc Sulfate	Work Days Lost	93.5	Standard Deviation 9.3	Hours
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents	Inpatient Zinc Sulfate	Work Days Lost	34	Standard Deviation 27.5	Hours

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Outpatient Zinc Sulfate	31
Overall Study	STARTED	Inpatient Zinc Sulfate	5
Overall Study	STARTED	Outpatient Placebo	30
Overall Study	STARTED	Inpatient Placebo	5
Overall Study	COMPLETED	Outpatient Zinc Sulfate	23
Overall Study	COMPLETED	Inpatient Zinc Sulfate	5
Overall Study	COMPLETED	Outpatient Placebo	21
Overall Study	COMPLETED	Inpatient Placebo	5
Overall Study	NOT COMPLETED	Outpatient Zinc Sulfate	8
Overall Study	NOT COMPLETED	Inpatient Zinc Sulfate	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	discontinued due to vomiting/tast	Gastrointestinal disorders	Outpatient Zinc Sulfate	2	23	4
other	discontinued due to vomiting/tast	Gastrointestinal disorders	Inpatient Zinc Sulfate	0	5	0
other	discontinued due to vomiting/tast	Gastrointestinal disorders	Outpatient Placebo	2	21
other	discontinued due to vomiting/tast	Gastrointestinal disorders	Inpatient Placebo	0	5
serious	Surgical abdomen	Gastrointestinal disorders	Outpatient Zinc Sulfate	0	23	0
serious	Surgical abdomen	Gastrointestinal disorders	Inpatient Zinc Sulfate	0	5	0
serious	Surgical abdomen	Gastrointestinal disorders	Outpatient Placebo	0	21
serious	Surgical abdomen	Gastrointestinal disorders	Inpatient Placebo	0	5
serious	Hospitalization after starting the study protocol within 14 days	Gastrointestinal disorders	Outpatient Zinc Sulfate	1	23	1
serious	Hospitalization after starting the study protocol within 14 days	Gastrointestinal disorders	Inpatient Zinc Sulfate	0	5	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Outpatient Zinc Sulfate	0	23
Total, all-cause mortality	Inpatient Zinc Sulfate	0	5
Total, all-cause mortality	Outpatient Placebo	0	21
Total, all-cause mortality	Inpatient Placebo	0	5
Total, other adverse events	Outpatient Zinc Sulfate	2	23
Total, other adverse events	Inpatient Zinc Sulfate	0	5
Total, other adverse events	Outpatient Placebo	2	21
Total, other adverse events	Inpatient Placebo	0	5
Total, serious adverse events	Outpatient Zinc Sulfate	1	23
Total, serious adverse events	Inpatient Zinc Sulfate	0	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01198587

GET https://conductscience.org/api/trials/v1/NCT01198587/registered

API reference For AI assistants