Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-04-10 @ 12:01 AM
Study NCT ID:
NCT02160405
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2014-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Iron Levels by the Inclusion of Native Potato in the Diet of Children From 2 to 5 Years, ICBF Beneficiaries. Nariño. Colombia. Cluster Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-06', 'studyFirstSubmitDate': '2014-05-08', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weight', 'timeFrame': '11 weeks'}, {'measure': 'Height', 'timeFrame': '11 Weeks', 'description': 'Changes in Height over the time'}, {'measure': 'food intake', 'timeFrame': '11 Weeks', 'description': 'Changes in food intake in the period'}, {'measure': 'supplement of micronutrient', 'timeFrame': '11 Weeks'}], 'primaryOutcomes': [{'measure': 'serum ferritin leves', 'timeFrame': '11 Weeks'}, {'measure': 'Serum transferrin levels', 'timeFrame': '11 weeks'}], 'secondaryOutcomes': [{'measure': 'Haemoglobin', 'timeFrame': '11 Weeks'}]}, 'conditionsModule': {'keywords': ['Iron levels'], 'conditions': ['Effect on Iron Levels']}, 'descriptionModule': {'briefSummary': "Nutritional deficiencies can lead to a number of health problems in children. In Latin America and the Caribbean countries, are registered so much problems of insufficient ingestion of food as of imbalances in the composition of the diet. These latter are expressed in the absence of micronutrients (iron, iodine, zinc, vitamin A), becoming a major health burden in developing countries. Being the globally's leading risk factor for disease and death, with hundreds of millions of pregnant women and young children particularly affected.\n\nJustification: In Nariño, Colombia higher levels of malnutrition are presented with respect to country, just as micronutrient deficiency in children 1 to 4 years is higher than the national average. Most of these households are poor families with restrictions on access to food sources of these micronutrients, which is reported in a consumption of fruits, vegetables, milk products and meat, less than the national average. In this place is developing a project that aims to improve potato in higher yield, nutrition and resistance, for contribute to increase food security of native communities.\n\nObjective: Evaluate the effect on iron levels generated by the inclusion of native potato in the diet of children aged 2-5 years in institutional beneficiaries modality ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto. Nariño. Colombia\n\nMethods:\n\nDesign: A cluster randomized controlled trial. Open label Setting: 6 clusters, municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto (two towns), which will be randomly assigned to 2 groups: the treatment group that receives native potato, and the control group that receives traditional potato, that will be include in the usual Institution meal Participants: children from 2 to 5 years, beneficiaries of programs in institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto.\n\nMain outcome measures: serum ferritin and transferrin levels\n\nThe study was conducted in the form of institutional programs ICBF, in the municipalities of Carlosama, Guachucal, Túquerres, Cumbal and Pasto. Colombia. One hypothesis to a queue based on the changes that occur over time after surgery in the mean values (μ) of serum ferritin in the treatment group compared with the control group. A sample size of 212 children were calculated. The study has been presented and approved by the Ethics Committee of the Faculty of Medicine of the National University of Colombia and the Institutional Review Board of the participating institution. All parents of participating children must sign a written form to accept the voluntary participation of their child in the study.", 'detailedDescription': '6 clusters, municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto (two towns), which will be randomly assigned to 2 groups: the treatment group that receives native potato, and the control group that receives traditional potato, that will be include in the usual Institution meal'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children from 2 to 5 years, beneficiaries of programs in institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto\n\nExclusion Criteria:\n\n* Children who met inclusion criteria but are not allowed to participate, refuse systematically to the test or don't go regularly to the institution"}, 'identificationModule': {'nctId': 'NCT02160405', 'briefTitle': 'Effect on Iron Levels by the Inclusion of Native Potato in the Diet of Children From 2 to 5 Years, ICBF Beneficiaries. Nariño. Colombia. Cluster Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de Colombia'}, 'officialTitle': 'Effect on Iron Levels by the Inclusion of Native Potato in the Diet of Children From 2 to 5 Years, ICBF Beneficiaries in the Municipalities of Carlosama, Cumbal, Guachucal, Túquerres y Pasto. Nariño. Colombia. Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '74282013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal diet', 'interventionNames': ['Dietary Supplement: native potato']}], 'interventions': [{'name': 'native potato', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Normal diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pasto', 'state': 'Departamento de Nariño', 'country': 'Colombia', 'facility': 'Centros de Desarrollo Infantil Institucional', 'geoPoint': {'lat': 1.21456, 'lon': -77.27846}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional de Colombia', 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University', 'class': 'OTHER'}, {'name': 'Trade and Development Canada and Canadian International Development Agency (CIDA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}