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Zinc Dosing Trial - Does Dose Reduction Reduce Side Effects But Retain Efficacy in Diarrhoea Management (ZTDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078842
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Center for Public Health Kinetics
Muhimbili University of Health and Allied Sciences
Boston Children's Hospital
Information provided by (Responsible Party):
Ayesha De Costa, World Health Organization

Brief Summary:

Diarrhoea continues to be a major cause of child deaths. Current treatment of acute watery diarrhoea includes oral rehydration solution (ORS), zinc and continued feeding. The use of zinc is based on a number of studies that showed that zinc reduces the duration and severity of diarrhoea. The recommended dose of zinc in 6-59 month old children is 20mg/day for 10-14 days. This dose is associated with an increased risk of vomiting. No dosing studies are available to determine the optimal dose of zinc, which while maintaining the benefits also has a low risk of vomiting.

The investigators will conduct a double-blind randomized controlled trial of three doses of zinc (20mg/day, 10mg/day and 5mg/day) in two settings - one in Sub-Saharan Africa and the other in South Asia. The study population will be 4500 children with diarrhoea of less than 72 hours duration who are aged 6-59 months. They will be recruited from outpatient health facilities. All enrolled children will receive ORS and continued feeding as recommended by the World Health Organization. Those allocated to the standard zinc dose will receive an oral dispersible tablet with 20mg zinc daily for 14 days. Those allocated to lower dose zinc will receive identical tablets with either 10mg or 5mg zinc daily for 14 days. Enrolled children will be followed by until recovery from diarrhoea or 15 days after enrolment, whichever is later. In addition, study children will be assessed again at thirty (30), forty-five (45), and sixty (60) days to estimate impact on post illness outcomes. Primary outcomes will be mean duration of diarrhoea, proportion of episodes that last longer than 5 days, mean number of stools and proportion of children with vomiting.


Condition or disease Intervention/treatment Phase
Diarrhea Dietary Supplement: Zinc tablets, 20 mg per day Dietary Supplement: Zinc tablets, 10 mg per day Dietary Supplement: Zinc tablets, 5 mg per day Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All participants will get dispersible zinc tablets that, contain either 20 mg, 10 mg, or 5 mg of zinc. All tablets look and taste the same. Randomization and tablet package labelling was done in Geneva, and no-one at the trial sites knows the actual zinc content of tablets packaged for each participant number.
Primary Purpose: Treatment
Official Title: Establishing the Optimal Dose of Therapeutic Zinc Supplementation for the Treatment of Acute Diarrhea in Under Five Children - a Dose Response Trial in a South Asian and a Sub-Saharan African Setting
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Active Comparator: Zinc-20
Zinc tablets, 20 mg per day
Dietary Supplement: Zinc tablets, 20 mg per day
Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 20 mg of zinc

Experimental: Zinc-10
Zinc tablets, 10 mg per day
Dietary Supplement: Zinc tablets, 10 mg per day
Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 10 mg of zinc

Experimental: Zinc-05
Zinc tablets, 5 mg per day
Dietary Supplement: Zinc tablets, 5 mg per day
Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 5 mg of zinc




Primary Outcome Measures :
  1. Proportion with long duration of diarrhoea [ Time Frame: Measured daily for 15 days ]
    Diarrhoea continuing beyond five days

  2. Continuation of diarrhoea symptoms [ Time Frame: Measured daily for 15 days ]
    Total number of loose or watery stools after enrolment

  3. Proportion of children vomiting after zinc treatment [ Time Frame: Measured daily for 15 days ]
    Vomiting within 30 minutes of administration of zinc tablet


Secondary Outcome Measures :
  1. Proportion of children experiencing serious adverse events (SAEs) [ Time Frame: Measured until 60 days ]
    Serious adverse events (life-threatening or requiring hospitalization)

  2. Proportion with intermediate duration of diarrhoea [ Time Frame: Measured daily for 15 days ]
    Diarrhoea continuing beyond three days

  3. Proportion of guardians with positive attitude towards treatment [ Time Frame: Day 15 ]
    The guardians will be asked if was easy to administer the treatment, if they think the child liked the treatment, if they saw any changes in the children after the treatment and if they would recommend this treatment to their friends' children.

  4. Treatment adherence [ Time Frame: Measured daily for 15 days ]
    Mean number of tablets consumed by the study child during the 14 day treatment period.

  5. Mean serum plasma zinc concentration at Days 1, 3, 7, 15, 21 and 30 [ Time Frame: Days 1, 3, 7, 15, 21 and 30 ]
    Mean serum plasma zinc concentration at Days 1, 3, 7, 15, 21 and 30

  6. Illness symptoms between day 15 and 60 after the treatment [ Time Frame: Days 30, 45, 60 ]
    2-week period prevalence and number of days with diarrhoea, fever, or respiratory symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 to 59 completed months of age
  • Acute diarrhoea of less than 3 days at the time of screening or dysentery, defined as visible blood in the stool, of less than 3 days at the time of screening
  • Likely to stay within the study area for the next 2 months
  • Written informed consent from caretaker

Exclusion Criteria:

  • Presence of severe acute malnutrition (WHZ<-3 or oedema)
  • Presence of severe dehydration that cannot be corrected in 4 to 6 hours
  • Signs of severe pneumonia (WHO definition of pneumonia with danger signs), sepsis, rapid diagnostic test (RDT) -confirmed malaria or other severe illness
  • Previously or currently enrolled in the study
  • Currently enrolled in another study
  • Other child currently enrolled in the study in the same household
  • Not intending to remain in study area for the duration of the study
  • Parents refuse participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078842


Locations
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India
Centre for Public Health Kinetics
New Delhi, India
Tanzania
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Sponsors and Collaborators
Ayesha De Costa
Center for Public Health Kinetics
Muhimbili University of Health and Allied Sciences
Boston Children's Hospital
Investigators
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Study Director: Rajiv Bahl, MBBS World Health Organization
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ayesha De Costa, Scientist, World Health Organization
ClinicalTrials.gov Identifier: NCT03078842    
Other Study ID Numbers: ERC.0002738
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The exact mechanism of data sharing has not yet been decided among the researchers. But the study is funded by an Organization (Bill & Melinda Gates Foundation) that requires data sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs