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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02571764
Enrollment
248
Registered
2015-10-08
Start date
2015-09-30
Completion date
2017-09-30
Last updated
2018-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Acute Malnutrition

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.

Interventions

OTHERNutritional Oats Cookie

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Weight (kg) for height (cm) Z-score12 months

Secondary

MeasureTime frame
Weight (kg) gains12 months
height (cm) for age (months) Z-score12 months
weight (kg) for age (months) Z-score12 months
Mid-upper arm circumference (cm) (MUAC)12 hours
height (cm) gain12 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026