Back to resultsSupplementary Food for Moderate Acute Malnutrition in Children
Primary Purpose
Moderate Acute Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Nutritional Oats Cookie
Sponsored by
About this trial
This is an interventional basic science trial for Moderate Acute Malnutrition
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.
Sites / Locations
- Un Kilo de Ayuda
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nutritional Oats Cookie
Arm Description
Outcomes
Primary Outcome Measures
Weight (kg) for height (cm) Z-score
Secondary Outcome Measures
Weight (kg) gains
height (cm) for age (months) Z-score
weight (kg) for age (months) Z-score
Mid-upper arm circumference (cm) (MUAC)
height (cm) gain
Full Information
NCT ID
NCT02571764
First Posted
September 29, 2015
Last Updated
September 25, 2018
Sponsor
PepsiCo Global R&D
1. Study Identification
Unique Protocol Identification Number
NCT02571764
Brief Title
Supplementary Food for Moderate Acute Malnutrition in Children
Official Title
The Effect of Supplementary Food on Recovery From Moderate Acute Malnutrition in Pre-school Children in Rural Mexico
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PepsiCo Global R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Acute Malnutrition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional Oats Cookie
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Nutritional Oats Cookie
Primary Outcome Measure Information:
Title
Weight (kg) for height (cm) Z-score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight (kg) gains
Time Frame
12 months
Title
height (cm) for age (months) Z-score
Time Frame
12 months
Title
weight (kg) for age (months) Z-score
Time Frame
12 months
Title
Mid-upper arm circumference (cm) (MUAC)
Time Frame
12 hours
Title
height (cm) gain
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Osvaldo Talavera Piña, PhD
Organizational Affiliation
Universidad Autónoma del Estado de México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Un Kilo de Ayuda
City
Colonia Lomas De Chapultepec
State/Province
Distrito Federal
ZIP/Postal Code
11000
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Supplementary Food for Moderate Acute Malnutrition in Children
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