NCT02601742

Effectiveness of Oral Rehydration Therapy Supplemented With Zinc in the Management of Diarrhea Acute in Mexican Children: Randomized Double-blind Study

Status unknown Phase 3 Last updated 9 November 2015

What this trial tests

Phase 3 trial testing Zinc group in Diarrhea in 350 participants. Status unknown.

Timeline

1 November 2015

Primary endpoint
1 January 2016

1 November 2016

Quick facts

Lead sponsor	Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	350
Start date	1 November 2015
Primary completion	1 January 2016
Estimated completion	1 November 2016

Drugs / interventions tested

• Zinc group
• Placebo group

Conditions studied

• Diarrhea — all drugs for Diarrhea →
• Children — all drugs for Children →

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Who can join

Adults 6 Months to 5, any sex, with Diarrhea or Children. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of bowel movements per day
  Time frame: 4 months

Sponsor's own description

Acute diarrhea is the third cause of infant mortality in the world causing 15% of all deaths in children under 5 years and is responsible for nearly 1.4 million deaths in developing countries. It is considered a self-limiting disease and to this problem the recommendation of the World Health Organization (WHO) is the administration of zinc with low osmolarity oral dehydration salts for a period of 10-14 days which reduces the severity of the episode.

In Mexico COFEPRIS believes the zinc salt as a food supplement and not a drug and the above problem is presented in terms of prescribing and access of this salt to the general population. In Mexico the investigators have the provision and accessibility of low osmolarity oral dehydration salts supplemented with adequate doses of zinc, which is inexpensive for the general population and offering a solution in terms of supply and management.

The purpose of the study involves the evaluation Pedialyte diarrhea in the treatment of acute diarrhea in children under 5 years. The investigator sconsider the use of Pedialyte diarrhea eases their access to the population in general and it is low cost compared with the zinc salt that is sold only in specialized pharmacies under strict medical prescription Objective: Compare the duration of symptoms of acute diarrhea in the treatment with low osmolarity oral rehydration salts (Pedialyte) vs treatment of low osmolarity oral rehydration supplemented with zinc (Pedialyte diarrhea) Study Desing: Double blind, randomized, controlled.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Zinc as a Drug for Wilson's Disease, Non-Alcoholic Liver Disease and COVID-19-Related Liver Injury.
   Coni P, Pichiri G, Lachowicz JI, Ravarino A, et al · · 2021 · cited 17× · PMID 34771023 · DOI 10.3390/molecules26216614