Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-13 @ 3:08 AM
Study NCT ID:
NCT02572258
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2015-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplementary Food on Prevention of Moderate Malnutrition in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1048}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-10-07', 'lastUpdatePostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight (kg) for height (cm) Z-score', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Weight (kg) gains', 'timeFrame': '12 months'}, {'measure': 'height (cm) for age (months) Z-score', 'timeFrame': '12 months'}, {'measure': 'weight (kg) for age (months) Z-score', 'timeFrame': '12 months'}, {'measure': 'Mid-upper arm circumference (cm) (MUAC)', 'timeFrame': '12 months'}, {'measure': 'height (cm) gains', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Moderate Acute Malnutrition (MAM)']}, 'descriptionModule': {'briefSummary': '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.\n\nChildren 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* (2-5 years old), who are from low socioeconomic classes (E and D classes)\n* reside in rural areas, and with WHZ- between \\> -3 and ≤ -2, and\n* informed consent given by the subject's mother or caregiver\n\nExclusion Criteria:\n\n* Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)\n* Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)\n* (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).\n* Current consumption of other supplementary foods.\n* Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled."}, 'identificationModule': {'nctId': 'NCT02572258', 'briefTitle': 'Supplementary Food on Prevention of Moderate Malnutrition in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico', 'orgStudyIdInfo': {'id': 'PEP-1410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional oats cookie and educational session', 'description': 'Nutritional cookie with oats and nuts', 'interventionNames': ['Other: Nutritional cookie']}, {'type': 'NO_INTERVENTION', 'label': 'Educational session only'}], 'interventions': [{'name': 'Nutritional cookie', 'type': 'OTHER', 'armGroupLabels': ['Nutritional oats cookie and educational session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Colonia Lomas de Chapultepec', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Un Kilo de Ayuda'}], 'overallOfficials': [{'name': 'Juan Talavera, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Autónoma del Estado de México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}