Supplementary Food for Moderate Acute Malnutrition in Children

The Effect of Supplementary Food on Recovery From Moderate Acute Malnutrition in Pre-school Children in Rural Mexico

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.

Study Overview

• Status: Completed
• Conditions: Moderate Acute Malnutrition
• Intervention / Treatment: Other: Nutritional Oats Cookie

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Colonia Lomas De Chapultepec, Distrito Federal, Mexico, 11000
      • Un Kilo de Ayuda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Oats Cookie	Other: Nutritional Oats Cookie

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight (kg) for height (cm) Z-score	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight (kg) gains	12 months
height (cm) for age (months) Z-score	12 months
weight (kg) for age (months) Z-score	12 months
Mid-upper arm circumference (cm) (MUAC)	12 hours
height (cm) gain	12 months

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Juan Osvaldo Talavera Piña, PhD, Universidad Autonoma del Estado de Mexico

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: PEP-1409