Supplementary Food for Moderate Acute Malnutrition in Children

NCT ID: NCT02571764

Last Updated: 2018-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

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Children with moderate acute malnutrition will be recruited in order to receive an intervention which consists in the consumption of a single serving of SF-cookies daily, 7-days a week for 12 months and 12 educational sessions on health and nutrition.

Detailed Description

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Conditions

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Moderate Acute Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nutritional Oats Cookie

Group Type EXPERIMENTAL

Nutritional Oats Cookie

Intervention Type OTHER

Interventions

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Nutritional Oats Cookie

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children (2-5 years old), who are from low socioeconomic classes (E and D classes),
* reside in rural areas, and with WHZ- between \> -3 and ≤ -2, and
* informed consent given by the subject's mother or caregiver

Exclusion Criteria

* Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
* Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
* (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
* Current consumption of other supplementary foods.
* Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Osvaldo Talavera Piña, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Autónoma del Estado de México

Locations

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Un Kilo de Ayuda

Colonia Lomas de Chapultepec, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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PEP-1409

Identifier Type: -

Identifier Source: org_study_id

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