Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:15 PM
Study NCT ID:
NCT01917032
Status:
UNKNOWN
Last Update Posted:
2013-08-06
First Post:
2013-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007501', 'term': 'Iron'}, {'id': 'D015032', 'term': 'Zinc'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D014801', 'term': 'Vitamin A'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2013-08-02', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Child Growth Indicators', 'timeFrame': '10 weeks', 'description': 'Anthropometric measurements as indicators of child growth and nutritional status'}], 'primaryOutcomes': [{'measure': 'Hemoglobin', 'timeFrame': '10 weeks', 'description': 'Hemoglobin quantitation for laboratory tests (g/dl)'}], 'secondaryOutcomes': [{'measure': 'Transferrin', 'timeFrame': '10 weeks', 'description': 'Transferrin quantitation for laboratory tests (mg/dl)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trace Elements', 'Preschool', 'Malnutrition', 'Fortified Food'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': "Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries.\n\nQuestion: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013?\n\nHypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group.\n\nDesign: Randomized clinical trial, triple-blind and placebo-controlled.\n\nParticipants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu.\n\nIntervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo.\n\nOutcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '5 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Assistance to children's centres full day (8 hours).\n* Age 5 to 59 months.\n\nExclusion Criteria:\n\n* Anemia (hemoglobin less than 11 g / dl).\n* Current supplementation with a product formulated by a health professional as a part of a nutritional recovery.\n* Denial for informed consent signing by parents or legal guardians.\n* Diagnosis of severe acute malnutrition by anthropometric measurements."}, 'identificationModule': {'nctId': 'NCT01917032', 'briefTitle': 'Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín', 'organization': {'class': 'OTHER', 'fullName': 'CES University'}, 'officialTitle': 'Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'SPRINK001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sprinkles', 'description': 'Micronutrient Powder Sprinkles 1 gram orally on weekdays during 11 weeks', 'interventionNames': ['Dietary Supplement: Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin 1 gram orally on weekdays during 11 weeks', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Chispitas', 'Sprinkles'], 'description': '1 g orally on weekdays during 11 weeks', 'armGroupLabels': ['Sprinkles']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0574', 'city': 'Medellín', 'state': 'Ant', 'country': 'Colombia', 'contacts': [{'name': 'Viviana Ramírez, Nutricionist', 'role': 'CONTACT', 'email': 'nutricion@fan.org.co', 'phone': '5744480288'}], 'facility': 'Fundación de Atención a la Niñez (FAN)', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'centralContacts': [{'name': 'Cristian Vargas, MD', 'role': 'CONTACT', 'email': 'crivargas24@hotmail.com', 'phone': '573006099044'}, {'name': 'Juliana Orozco, Nutritionist', 'role': 'CONTACT', 'email': 'julianaorozcocano@hotmail.com', 'phone': '573205371487'}], 'overallOfficials': [{'name': 'Cristian Vargas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CES University'}, {'name': 'Juliana Orozco, Nutricionist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CES University'}, {'name': 'Juliana Sánchez, Dentist', 'role': 'STUDY_CHAIR', 'affiliation': 'CES University'}, {'name': 'Liliana Montoya, Epidemiology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CES University'}, {'name': 'Javier Chica, Veterinarian', 'role': 'STUDY_CHAIR', 'affiliation': 'CES University'}, {'name': 'Maylen Rojas, Epidemiology', 'role': 'STUDY_CHAIR', 'affiliation': 'CES University'}, {'name': 'Óscar Villada, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CES University'}, {'name': 'Alejandro Díaz, Pediatrist', 'role': 'STUDY_CHAIR', 'affiliation': 'CES University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CES University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'Cristian Vargas G. MD', 'investigatorAffiliation': 'CES University'}}}}