NCT02571764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 29, 2015

Last Update Submit

September 25, 2018

Conditions

Moderate Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Weight (kg) for height (cm) Z-score

    12 months

Secondary Outcomes (5)

  • 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 hours

  • height (cm) gain

    12 months

Study Arms (1)

Nutritional Oats Cookie

EXPERIMENTAL
Other: Nutritional Oats Cookie

Interventions

Nutritional Oats CookieOTHER
Nutritional Oats Cookie

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Un Kilo de Ayuda

Colonia Lomas de Chapultepec, Mexico City, 11000, Mexico

Location

Study Officials

  • Juan Osvaldo Talavera Piña, PhD

    Universidad Autónoma del Estado de México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 8, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

ME(1)