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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.
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
Exclusion
Elimination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc group | Active Comparator | Pedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days |
|
| Placebo group | Placebo Comparator | Pedialyte oral electrolyte solution, 330 ml per day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc group | Other | Pedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of bowel movements per day | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María del Carmen Yebra Cano, Medicina | Contact | 5585315297 | melitacar@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| María del Carmen Yebra Cano, Medicina | Secretaria de Marina-Armada de México (Mexican Navy) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22579125 | Background | 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. | |
| 22682449 |
| Label | URL |
|---|---|
| Encuesta Nacional de Salud y Nutrición 2012 | View source |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo group | Other | Pedialyte oral electrolyte solution, 330 ml per day for 7 days |
|
|
| Background |
| 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. |
| Background | 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 |
| 16740827 | 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. |
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| Background | Dr Rul L. Riveron Corteguera, Fisiopatología de la diarrea aguda, Hospital pediátrico docente de la Habana 2009 |
| 10801944 | 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. |
| 12424162 | Background | 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. |
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