Supplementary Food on Prevention of Moderate Malnutrition in Children

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

1048 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

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The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.

Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months

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Detailed Description

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Conditions

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Moderate Acute Malnutrition (MAM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nutritional oats cookie and educational session

Nutritional cookie with oats and nuts

Group Type EXPERIMENTAL

Nutritional cookie

Intervention Type OTHER

Educational session only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutritional cookie

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* (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