Supplementary Food on Prevention of Moderate Malnutrition in Children

Moderate Acute Malnutrition (MAM) Clinical Trial

Official title:

The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572258
• Other study ID #: PEP-1410
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2018
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.

Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1048
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• (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.

Related Conditions & MeSH terms

• Malnutrition
• Moderate Acute Malnutrition (MAM)

Intervention

Other:
• Nutritional cookie

Locations

Country	Name	City	State
Mexico	Un Kilo de Ayuda	Colonia Lomas De Chapultepec	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (kg) for height (cm) Z-score		12 months
Secondary	Weight (kg) gains		12 months
Secondary	height (cm) for age (months) Z-score		12 months
Secondary	weight (kg) for age (months) Z-score		12 months
Secondary	Mid-upper arm circumference (cm) (MUAC)		12 months
Secondary	height (cm) gains		12 months