Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-02 @ 2:41 PM
Study NCT ID:
NCT07041866
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2025-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "In this study, both participants and data collectors were blinded to the group assignments. Participants were unaware whether they were receiving the iron-fortified biscuit or the placebo biscuit, as both were similar in appearance and taste. Additionally, data collectors responsible for anthropometric and biological measurements were not informed of the participants' allocation to ensure objectivity in data collection. However, the study coordinators and investigators were aware of the intervention allocation due to the nature of the study design."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to one of two parallel groups: an intervention group receiving iron-fortified biscuits and a control group receiving placebo biscuits with similar appearance but without iron-rich ingredients. The intervention lasted for 3 months, and outcomes were assessed before and after the intervention period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 570}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sex (male/female)', 'timeFrame': 'at baseline'}, {'measure': 'Age of participants', 'timeFrame': 'At baseline and at 3 months (endline)'}], 'primaryOutcomes': [{'measure': 'Change in serum ferritin concentration (ng/mL)', 'timeFrame': 'At baseline and at 3 months (endline)'}, {'measure': 'Prevalence of iron deficiency', 'timeFrame': 'At baseline and at 3 months (endline)'}], 'secondaryOutcomes': [{'measure': 'Change in hemoglobin concentration (g/dL)', 'timeFrame': 'At baseline and at 3 months (endline)'}, {'measure': 'Prevalence of anemia (mild, moderate, severe)', 'timeFrame': 'At baseline and at 3 months (endline'}, {'measure': 'Change in BMI-for-age Z-score (BMIZ-WHO)', 'timeFrame': 'At baseline and at 3 months (endline'}, {'measure': 'prevalence of thinness (BMIZ < -2 SD)', 'timeFrame': 'At baseline and at 3 months (endline)'}, {'measure': 'C-reactive protein (CRP) concentration', 'timeFrame': 'At baseline and at 3 months (endline)'}, {'measure': 'Alpha-1-acid glycoprotein (AGP) concentration', 'timeFrame': 'At baseline and at 3 months (endline)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fortified biscuit, school-aged children, iron status, anemia, nutritional status, Senegal.'], 'conditions': ['This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the impact of fortified biscuit consumption on the iron status of school-aged children in rural Kaolack.\n\nThe main question it aims to answer is:\n\n• Does the consumption of iron-fortified biscuits improve the iron status of school-aged children? Researchers compared the iron-fortified biscuit to a placebo (a biscuit similar in appearance but without iron-rich ingredients) to measure its effectiveness.\n\nParticipants:\n\n* Consumed either the fortified biscuit or the placebo daily for 3 months\n* Took part in data collection after 3 months of biscuit consumption'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6 to 16 years\n* Enrolled in one of the two selected elementary schools (French or Franco-Arab)\n* Availability to participate throughout the 3-month intervention period\n* Obtained written informed consent from parent or guardian Verbal assent obtained from the child\n\nExclusion Criteria:\n\n* Children diagnosed with sickle cell disease (SCD)\n* Children currently under iron supplementation or treatment at the start of the study\n* Refusal to participate or withdrawal of consent at any time'}, 'identificationModule': {'nctId': 'NCT07041866', 'briefTitle': 'Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children', 'organization': {'class': 'OTHER', 'fullName': 'Universite du Sine Saloum Elhadj Ibrahima Niasse'}, 'officialTitle': 'Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children in a Rural Setting in Kaolack, Central Senegal', 'orgStudyIdInfo': {'id': 'USSEIN2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'This group included 286 school-aged children (6-16 years) enrolled in a French public elementary school in Keur Socé.', 'interventionNames': ['Dietary Supplement: Fortified Biscuit with Local Iron-Rich Ingredients']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'This group consisted of 210 children (aged 6-16 years) from a Franco-Arabic elementary school in the same locality.', 'interventionNames': ['Dietary Supplement: Non-Fortified Biscuit']}], 'interventions': [{'name': 'Fortified Biscuit with Local Iron-Rich Ingredients', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consumed one fortified biscuit per day, five days a week (school days), for a period of three months. The biscuit was formulated using wheat flour, millet, maize, peanut paste, sugar, and was filled with a blend of Moringa oleifera, Hibiscus sabdariffa, Adansonia digitata, and Detarium senegalense-all selected for their high iron and vitamin C content. The iron content was approximately 4 mg per 100 g.', 'armGroupLabels': ['Experimental group']}, {'name': 'Non-Fortified Biscuit', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants received a placebo biscuit daily for the same period and frequency as the intervention group. The placebo biscuit was visually and texturally identical to the fortified biscuit but did not contain the micronutrient-rich filling.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaolack', 'country': 'Senegal', 'facility': 'École Élémentaire de Keur Socé City: Kaolack Country: Senegal', 'geoPoint': {'lat': 14.15197, 'lon': -16.07259}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universite du Sine Saloum Elhadj Ibrahima Niasse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}