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DiarrheaPhase 3NCT02601742

Effectiveness of Oral Rehydration Therapy Supplemented With Zinc in the Management of Diarrhea Acute

A Phase 3 study testing Zinc group in people with Diarrhea and Children, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 5 years
Conditions the study is for
Diarrhea, Children
What is being tested?
Zinc group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
No sites listed yet
Study dates
Nov 2015to Nov 2016
Phase
Phase 3
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 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Patients with vomit (10 or more)
  • Hemodynamic Instability
  • Severe dehydration
  • Patients with heart disease
  • Patients with a history of prematurity.
  • Patients with chronic diarrhea
Show all 9Show fewer
  • Patients whose parents refuse to provide written informed consent
  • Patients who do not comply with treatment correctly
  • Patients with suspected surgical pathology

Trial locations and contacts

No sites are listed yet.

María del Carmen Yebra Cano, Medicina contact

5585315297

melitacar@hotmail.com

About this study

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

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.

Read the detailed description

It will be conducted a randomized controlled double-blind in the Emergency service of the Naval General Hospital of High Specialty in the Mexico City. The period of patient inclusion in the study is October 2015 to November 2016.

The patients selections is the children between 6 months and 5 years who come to the emergency room with symptoms of acute diarrhea with up to 48 hours of starting the disease, it will proceed to questioning and to assess vital signs and thorough physical examination for determine the degree of dehydration, nutritional status and rule out diagnosis of abdominal pathology emergency.

Selection criteria Inclusion

  • 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

Exclusion

  • Patients with vomit (10 or more)
  • Hemodynamic Instability
  • Dehydration severe
  • 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

Elimination

  • Patients with severe dehydration
  • Patients in whom the parents decline for informed consent
Conditions
Diarrhea, Children
Being tested
Zinc group, Placebo group
Keywords
zinc, Duration
Medical subject headings
Diarrhea

What participants receive

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

  • Zinc groupOther

    Also called Pedialyte diarrhea 45

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

  • Placebo groupOther

    Also called Pedialyte SR 45

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

Study groups in NCT02601742
Study groupRoleWhat they receive
Zinc groupActive comparatorPedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days
Receives: Other: Zinc group
Placebo groupPlacebo comparatorPedialyte oral electrolyte solution, 330 ml per day for 7 days
Receives: Other: Placebo group

What is being measured

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

  1. Number of bowel movements per day

    Measured: 4 months

Timeline

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

  1. First posted10 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJan 2016 (estimated)
  4. Study completionNov 2016 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02601742
Sponsor's protocol ID
HGNAE-09
Status last verified
Oct 2015
First submitted
9 Nov 2015
Last updated
10 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22579125

  • 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.

    PubMed 22682449

  • 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

  • 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

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

  • 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

  • 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.

    PubMed 16740827

  • 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.

    PubMed 16541699

  • 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.

    PubMed 22696352

  • 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.

    PubMed 25176404

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

  • 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.

    PubMed 10801944

  • 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.

    PubMed 12424162

  • 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.

    PubMed 19876545

  • 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.

    PubMed 20515554

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zinc group in people with Diarrhea and Children, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.

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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact María del Carmen Yebra Cano, Medicina (5585315297, melitacar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of bowel movements per day (time frame: 4 months). 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 NCT02601742, which also lists 15 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 10 Nov 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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