Supplementary Food on Prevention of Moderate Malnutrition in Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02572258

Enrollment

1048

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 (MAM)

Brief 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

Interventions

OTHERNutritional cookie

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Weight (kg) for height (cm) Z-score	12 months

Secondary

Measure	Time frame
Weight (kg) gains	12 months
height (cm) for age (months) Z-score	12 months
weight (kg) for age (months) Z-score	12 months
Mid-upper arm circumference (cm) (MUAC)	12 months
height (cm) gains	12 months

Countries

Mexico

Outcome results

None listed

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