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DiarrheaZTDTNCT03078842

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

A study testing Zinc tablets, 20 mg per day, Zinc tablets, 10 mg per day and Zinc tablets, 5 mg per day in people with Diarrhea, run by Ayesha De Costa at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 59 months
Conditions the study is for
Diarrhea
What is being tested?
Zinc tablets, 20 mg per day, Zinc tablets, 10 mg per day and Zinc tablets, 5 mg per day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,500 participants
Where
2 sitesin 2 countries
Study dates
23 Jan 2017to 1 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

India1 site

  • Centre for Public Health Kinetics

    New Delhi

Other trials in India

Tanzania1 site

  • Muhimbili University of Health and Allied Sciences

    Dar es Salaam

Other trials in Tanzania

About this study

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

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.

Conditions
Diarrhea
Being tested
Zinc tablets, 20 mg per day, Zinc tablets, 10 mg per day, Zinc tablets, 5 mg per day
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zinc tablets, 20 mg per dayDietary supplement

    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

  • Zinc tablets, 10 mg per dayDietary supplement

    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

  • Zinc tablets, 5 mg per dayDietary supplement

    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

Study groups in NCT03078842
Study groupRoleWhat they receive
Zinc-20Active comparatorZinc tablets, 20 mg per day
Receives: Dietary Supplement: Zinc tablets, 20 mg per day
Zinc-10ExperimentalZinc tablets, 10 mg per day
Receives: Dietary Supplement: Zinc tablets, 10 mg per day
Zinc-05ExperimentalZinc tablets, 5 mg per day
Receives: Dietary Supplement: Zinc tablets, 5 mg per day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion with long duration of diarrhoea

    Diarrhoea continuing beyond five days

    Measured: Measured daily for 15 days

  2. Continuation of diarrhoea symptoms

    Total number of loose or watery stools after enrolment

    Measured: Measured daily for 15 days

  3. Proportion of children vomiting after zinc treatment

    Vomiting within 30 minutes of administration of zinc tablet

    Measured: Measured daily for 15 days

Secondary outcomes (6)

  1. Proportion of children experiencing serious adverse events (SAEs)

    Serious adverse events (life-threatening or requiring hospitalization)

    Measured: Measured until 60 days

  2. Proportion with intermediate duration of diarrhoea

    Diarrhoea continuing beyond three days

    Measured: Measured daily for 15 days

  3. Proportion of guardians with positive attitude towards treatment

    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.

    Measured: Day 15

  4. Treatment adherence

    Mean number of tablets consumed by the study child during the 14 day treatment period.

    Measured: Measured daily for 15 days

  5. Mean serum plasma zinc concentration at Days 1, 3, 7, 15, 21 and 30

    Mean serum plasma zinc concentration at Days 1, 3, 7, 15, 21 and 30

    Measured: Days 1, 3, 7, 15, 21 and 30

  6. Illness symptoms between day 15 and 60 after the treatment

    2-week period prevalence and number of days with diarrhoea, fever, or respiratory symptoms

    Measured: Days 30, 45, 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2017
  2. Study start23 Jan 2017
  3. Primary completion8 Feb 2019
  4. Study completion1 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03078842
Sponsor's protocol ID
ERC.0002738
Acronym
ZTDT
Status last verified
Oct 2020
First submitted
7 Mar 2017
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Edwards JG, Dhingra P, Liu E, Dhingra U, Dutta A, Sudfeld CR, Deb S, Somji S, Aboud S, Kisenge R, Sazawal S, Ashorn P, Simon J, Manji KP, Duggan CP. Identifying risk factors for vomiting during diarrhea: A secondary analysis of a randomized trial of zinc supplementation. J Pediatr Gastroenterol Nutr. 2025 Apr;80(4):598-610. doi: 10.1002/jpn3.12441. Epub 2025 Jan 13.

    PubMed 39806793

  • Kisenge R, Dhingra U, Rees CA, Liu E, Dutta A, Saikat D, Dhingra P, Somji S, Sudfeld C, Simon J, Ashorn P, Sazawal S, Duggan CP, Manji K. Risk factors for moderate acute malnutrition among children with acute diarrhoea in India and Tanzania: a secondary analysis of data from a randomized trial. BMC Pediatr. 2024 Jan 19;24(1):56. doi: 10.1186/s12887-024-04551-2.

    PubMed 38238656

  • Dhingra U, Kisenge R, Sudfeld CR, Dhingra P, Somji S, Dutta A, Bakari M, Deb S, Devi P, Liu E, Chauhan A, Kumar J, Semwal OP, Aboud S, Bahl R, Ashorn P, Simon J, Duggan CP, Sazawal S, Manji K. Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial. N Engl J Med. 2020 Sep 24;383(13):1231-1241. doi: 10.1056/NEJMoa1915905.

    PubMed 32966722

  • Somji SS, Dhingra P, Dhingra U, Dutta A, Devi P, Kumar J, Deb S, Semwal OP, Sazawal S, Manji K, Kisenge R, Bakari M, Aboud S, Liu E, Sudfeld C, Duggan CP, Ashorn P, Bahl R, Simon JL. Effect of dose reduction of supplemental zinc for childhood diarrhoea: study protocol for a double-masked, randomised controlled trial in India and Tanzania. BMJ Paediatr Open. 2019 Apr 24;3(1):e000460. doi: 10.1136/bmjpo-2019-000460. eCollection 2019.

    PubMed 31206083

Questions about this trial

What is this clinical trial studying?

A study testing Zinc tablets, 20 mg per day, Zinc tablets, 10 mg per day and Zinc tablets, 5 mg per day in people with Diarrhea, run by Ayesha De Costa at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion with long duration of diarrhoea (time frame: Measured daily for 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03078842, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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