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Supplementary Food on Prevention of Moderate Malnutrition in Children

PepsiCo logo

PepsiCo

Status

Completed

Conditions

Moderate Acute Malnutrition (MAM)

Treatments

Other: Nutritional cookie

Study type

Interventional

Funder types

Industry

Identifiers

NCT02572258
PEP-1410

Details and patient eligibility

About

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

Enrollment

1,048 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,048 participants in 2 patient groups

Nutritional oats cookie and educational session
Experimental group
Description:
Nutritional cookie with oats and nuts
Treatment:
Other: Nutritional cookie
Educational session only
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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