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Supplementary Food for Moderate Acute Malnutrition in Children

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PepsiCo

Status

Completed

Conditions

Moderate Acute Malnutrition

Treatments

Other: Nutritional Oats Cookie

Study type

Interventional

Funder types

Industry

Identifiers

NCT02571764
PEP-1409

Details and patient eligibility

About

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.

Enrollment

248 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

248 participants in 1 patient group

Nutritional Oats Cookie
Experimental group
Treatment:
Other: Nutritional Oats Cookie

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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