NCT02601742

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 10, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

November 9, 2015

Last Update Submit

November 9, 2015

Conditions

DiarrheaChildren

Keywords

zincDuration

Outcome Measures

Primary Outcomes (1)

  • Number of bowel movements per day

    4 months

Study Arms (2)

Zinc group

ACTIVE COMPARATOR

Pedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days

Other: Zinc group

Placebo group

PLACEBO COMPARATOR

Pedialyte oral electrolyte solution, 330 ml per day for 7 days

Other: Placebo group

Interventions

Zinc groupOTHER

Pedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days

Also known as: Pedialyte diarrhea 45
Zinc group
Placebo groupOTHER

Pedialyte oral electrolyte solution, 330 ml per day for 7 days

Also known as: Pedialyte SR 45
Placebo group

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients 6 months to 5 years old with acute diarrhea
  • Patients in their first 48 hours of onset diarrhea
  • Dehydration mild to moderate according to WHO clinical scale
  • Both sexes
  • Outpatients

You may not qualify if:

  • Patients with vomit (10 or more)
  • Hemodynamic Instability
  • Severe dehydration
  • Patients with heart disease
  • Patients with a history of prematurity.
  • Patients with chronic diarrhea
  • Patients whose parents refuse to provide written informed consent
  • Patients who do not comply with treatment correctly
  • Patients with suspected surgical pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.

    PMID: 22579125BACKGROUND

  • Gupta GR. Tackling pneumonia and diarrhoea: the deadliest diseases for the world's poorest children. Lancet. 2012 Jun 9;379(9832):2123-4. doi: 10.1016/S0140-6736(12)60907-6. No abstract available.

    PMID: 22682449BACKGROUND

  • Aurelio Mejia y cosl., Analisis de costo beneficio de la suplementación con Zinc en el tratamiento de la diarrea aguda en niños menores de 5 años en Colombia, publicado en ESPGHAN 2015

    BACKGROUND

  • Scrimgeour, A.; Condlin, M.; Otieno, L.; Bovill, M. Zinc intervention strategies: Costs and health benefits. In Nutrients, Dietary Supplements, and Nutriceuticals; Gerald, J.K., Watson, R.R., Preedy, V.R., Eds.; Humana Press: 201

    BACKGROUND

  • WHO/UNICEF. Joint Statement on the Clinical Management of Acute Diarrhoea; UNICEF: 2004

    BACKGROUND

  • Benguigui Y, Bernal C, Figueroa D, eds. Manual de Tratamiento de la Diarrea en Nin˜os. Washington, DC: Panamerican Health Organization/ Organización Panamericana de la Salud; 2008

    BACKGROUND

  • Malek MA, Curns AT, Holman RC, Fischer TK, Bresee JS, Glass RI, Steiner CA, Parashar UD. Diarrhea- and rotavirus-associated hospitalizations among children less than 5 years of age: United States, 1997 and 2000. Pediatrics. 2006 Jun;117(6):1887-92. doi: 10.1542/peds.2005-2351.

    PMID: 16740827BACKGROUND

  • Majowicz SE, McNab WB, Sockett P, Henson TS, Dore K, Edge VL, Buffett MC, Fazil A, Read S, McEwen S, Stacey D, Wilson JB. Burden and cost of gastroenteritis in a Canadian community. J Food Prot. 2006 Mar;69(3):651-9. doi: 10.4315/0362-028x-69.3.651.

    PMID: 16541699BACKGROUND

  • Lazzerini M, Ronfani L. Oral zinc for treating diarrhoea in children. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD005436. doi: 10.1002/14651858.CD005436.pub3.

    PMID: 22696352BACKGROUND

  • Liberato SC, Singh G, Mulholland K. Zinc supplementation in young children: A review of the literature focusing on diarrhoea prevention and treatment. Clin Nutr. 2015 Apr;34(2):181-8. doi: 10.1016/j.clnu.2014.08.002. Epub 2014 Aug 13.

    PMID: 25176404BACKGROUND

  • Dr Rul L. Riveron Corteguera, Fisiopatología de la diarrea aguda, Hospital pediátrico docente de la Habana 2009

    BACKGROUND

  • King JC, Shames DM, Woodhouse LR. Zinc homeostasis in humans. J Nutr. 2000 May;130(5S Suppl):1360S-6S. doi: 10.1093/jn/130.5.1360S.

    PMID: 10801944BACKGROUND

  • Baqui AH, Black RE, El Arifeen S, Yunus M, Chakraborty J, Ahmed S, Vaughan JP. Effect of zinc supplementation started during diarrhoea on morbidity and mortality in Bangladeshi children: community randomised trial. BMJ. 2002 Nov 9;325(7372):1059. doi: 10.1136/bmj.325.7372.1059.

    PMID: 12424162BACKGROUND

  • Fischer Walker CL, Fontaine O, Young MW, Black RE. Zinc and low osmolarity oral rehydration salts for diarrhoea: a renewed call to action. Bull World Health Organ. 2009 Oct;87(10):780-6. doi: 10.2471/blt.08.058990.

    PMID: 19876545BACKGROUND

  • Maggini S, Wenzlaff S, Hornig D. Essential role of vitamin C and zinc in child immunity and health. J Int Med Res. 2010 Mar-Apr;38(2):386-414. doi: 10.1177/147323001003800203.

    PMID: 20515554BACKGROUND

Related Links

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • María del Carmen Yebra Cano, Medicina

    Secretaria de Marina-Armada de México (Mexican Navy)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María del Carmen Yebra Cano, Medicina

CONTACT

5585315297melitacar@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 10, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

November 1, 2016

Last Updated

November 10, 2015

Record last verified: 2015-10