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Supplementary Food on Prevention of Moderate Malnutrition in Children

Primary Purpose

Moderate Acute Malnutrition (MAM)

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Nutritional cookie

About this trial

This is an interventional basic science trial for Moderate Acute Malnutrition (MAM)

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Un Kilo de Ayuda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutritional oats cookie and educational session

Educational session only

Arm Description

Nutritional cookie with oats and nuts

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) gains

Full Information

NCT ID

NCT02572258

First Posted

September 29, 2015

Last Updated

September 25, 2018

Sponsor

PepsiCo Global R&D

1. Study Identification

Unique Protocol Identification Number

NCT02572258

Brief Title

Supplementary Food on Prevention of Moderate Malnutrition in Children

Official Title

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate Acute Malnutrition (MAM)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1048 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nutritional oats cookie and educational session

Arm Type

Experimental

Arm Description

Nutritional cookie with oats and nuts

Arm Title

Educational session only

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Nutritional 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 months

Title

height (cm) gains

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

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Talavera, 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 on Prevention of Moderate Malnutrition in Children

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