Supplementary Food for Moderate Acute Malnutrition in Children

Not Applicable

Completed

• Conditions: Moderate Acute Malnutrition
• Interventions: Other: Nutritional Oats Cookie

• Registration Number: NCT02571764
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional Oats Cookie	Nutritional Oats Cookie	-

Primary Outcome Measures

Name	Time	Method
Weight (kg) for height (cm) Z-score	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Un Kilo de Ayuda; 🇲🇽 Colonia Lomas De Chapultepec, Distrito Federal, Mexico