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OpenTrials
Completed

NCT Number: NCT02572258

Supplementary Food on Prevention of Moderate Malnutrition in Children

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

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Key information

Conditions

Moderate Acute Malnutrition (MAM)

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Un Kilo de Ayuda

Colonia Lomas de Chapultepec, Mexico City, 11000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional cookie

Other

Primary outcomes

  1. Weight (kg) for height (cm) Z-score

    Time frame: 12 months

Secondary outcomes

  1. Weight (kg) gains

    Time frame: 12 months

  2. height (cm) for age (months) Z-score

    Time frame: 12 months

  3. weight (kg) for age (months) Z-score

    Time frame: 12 months

  4. Mid-upper arm circumference (cm) (MUAC)

    Time frame: 12 months

  5. height (cm) gains

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2015
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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