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

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Status and phase: Unknown; Phase 3

Conditions: Diarrhea; Children

Treatments: Other: Placebo group; Other: Zinc group

Study type: Interventional

Funder types: Other

Identifiers

NCT02601742

HGNAE-09

Details and patient eligibility

About

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.

Full 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

Enrollment: 350 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

350 participants in 2 patient groups, including a placebo group

Zinc group

Active Comparator group

Description:

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

Treatment:

Other: Zinc group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo group