Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02571764
NCT02571764CompletedNot 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 enrollmentStarted: September 2015Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
248
Locations
1
Primary Endpoint
Weight (kg) for height (cm) Z-score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
2 Years to 5 Years (Child)
Sex
All
Accepts 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.

Arms & Interventions

Nutritional Oats Cookie

Experimental

Intervention: Nutritional Oats Cookie (Other)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian InfantsGrowth DisordersInfant MalnutritionMicronutrient DeficiencyProtein MalnutritionInfant Morbidity
NCT03181178Nevin Scrimshaw International Nutrition Foundation1,204
Active, not recruiting
Not Applicable
Giving Resources to lOw-income Children to Enhance RecoverYDischarged Pediatric Patients and Their Families
NCT06560229Children's Hospital Medical Center, Cincinnati400
Completed
Not Applicable
Trial of Nutritional Supplementation in Infants Born Small for Gestational AgeBirth Weight
NCT00134771Institute of Child Health
Completed
Phase 3
Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for InfantsMalnutrition
NCT00131209Tampere University180
Completed
Phase 2
Community-based Follow-up of Severely Malnourished ChildrenMalnourished Children
NCT01157741International Centre for Diarrhoeal Disease Research, Bangladesh507