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Clinical Trials/NCT02571764
NCT02571764
Completed
Not Applicable

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

PepsiCo Global R&D1 site in 1 country248 target enrollmentSeptember 2015
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ConditionsModerate Acute Malnutrition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Moderate Acute Malnutrition
Sponsor
PepsiCo Global R&D
Enrollment
248
Locations
1
Primary Endpoint
Weight (kg) for height (cm) Z-score
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
September 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Weight (kg) for height (cm) Z-score

Time Frame: 12 months

Secondary Outcomes

  • 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)

Study Sites (1)

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