NCT03078842: ZTDT

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

Completed NA Last updated 8 October 2020

What this trial tests

NA trial testing Zinc tablets, 20 mg per day in Diarrhea in 4,500 participants. Completed in 1 February 2020.

Timeline

23 January 2017

Primary endpoint
8 February 2019

1 February 2020

Quick facts

Lead sponsor	Ayesha De Costa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	4,500
Start date	23 January 2017
Primary completion	8 February 2019
Estimated completion	1 February 2020
Sites	2 locations across Tanzania, India

Drugs / interventions tested

• Zinc tablets, 20 mg per day
• Zinc tablets, 10 mg per day
• Zinc tablets, 5 mg per day

Conditions studied

• Diarrhea — all drugs for Diarrhea →

Sponsor

Ayesha De Costa

Who can join

Adults 6 Months to 59 Months, any sex, with Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial.
   Dhingra U, Kisenge R, Sudfeld CR, Dhingra P, et al · · 2020 · cited 43× · PMID 32966722 · DOI 10.1056/nejmoa1915905
2. Effect of dose reduction of supplemental zinc for childhood diarrhoea: study protocol for a double-masked, randomised controlled trial in India and Tanzania.
   Somji SS, Dhingra P, Dhingra U, Dutta A, et al · · 2019 · cited 7× · PMID 31206083 · DOI 10.1136/bmjpo-2019-000460
3. Identifying risk factors for vomiting during diarrhea: A secondary analysis of a randomized trial of zinc supplementation.
   Edwards JG, Dhingra P, Liu E, Dhingra U, et al · · 2025 · PMID 39806793 · DOI 10.1002/jpn3.12441
4. Risk factors for moderate acute malnutrition among children with acute diarrhoea in India and Tanzania: a secondary analysis of data from a randomized trial.
   Kisenge R, Dhingra U, Rees CA, Liu E, et al · · 2024 · PMID 38238656 · DOI 10.1186/s12887-024-04551-2