Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-01 @ 3:11 PM
Study NCT ID:
NCT07100795
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin B12, Folic Acid and Vitamin D Status in Women of Reproductive Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-27', 'studyFirstSubmitDate': '2025-07-27', 'studyFirstSubmitQcDate': '2025-07-27', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of folic acid', 'timeFrame': 'At enrollment (single visit)', 'description': 'Measured in serum samples using Alinity i immunoassay system.'}, {'measure': 'Serum concentration of vitamin B12', 'timeFrame': 'At enrollment (single visit)', 'description': 'Measured in serum samples using Alinity i immunoassay system.'}, {'measure': 'Serum concentration of vitamin D', 'timeFrame': 'At enrollment (single visit)', 'description': 'Measured in serum samples using Alinity i immunoassay system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin B12', 'Vitamin D', 'Folic acid'], 'conditions': ['Vitamin D, Vitamin B 12 and Folic Acid Concentrations', 'Micronutrient Status in Women of Reproductive Age', 'Vitamin Status Assessment']}, 'descriptionModule': {'briefSummary': 'This cross-sectional observational study aims to assess serum concentrations of vitamin B12, folic acid, and vitamin D in women of reproductive age in Herzegovina. The study is led by Professor Vajdana Tomić, MD, PhD, who serves as the Principal Investigator, at the Faculty of Health Studies, University of Mostar, Bosnia and Herzegovina. The goal is to determine whether current international supplementation guidelines reflect the actual micronutrient status of this population. A total of 360 women aged 18-49 will be enrolled between December 2024 and December 2025 after providing informed consent. The findings will inform population-specific recommendations for micronutrient supplementation during the preconception period and pregnancy.\n\nThe study will be conducted at the Faculty of Health Studies, University of Mostar, Bosnia and Herzegovina.', 'detailedDescription': 'Micronutrient intake-particularly vitamin B12, folic acid, and vitamin D-is essential during the preconception period and pregnancy to support fetal growth and reduce the risk of adverse outcomes such as preterm birth, low birth weight, and congenital anomalies. However, excessive intake may carry potential risks, including epigenetic changes, insulin resistance, and increased incidence of childhood asthma and obesity. Additionally, folic acid may mask underlying vitamin B12 deficiency, delaying diagnosis and increasing the risk of neurological complications.\n\nThis cross-sectional study addresses the lack of region-specific data on micronutrient status among women of reproductive age in Herzegovina. Although international guidelines provide general recommendations, they may not reflect the actual needs of this population. The study aims to evaluate the prevalence of micronutrient deficiency, adequacy, or excess to guide the development of evidence-based, locally adapted supplementation strategies.\n\nA total of 360 women aged 18 to 49 will be enrolled between December 1, 2024, and December 1, 2025, after providing informed consent. Blood samples will be collected and centrifuged, and serum concentrations of vitamin B12, folic acid, and vitamin D will be measured using chemiluminescent microparticle immunoassays (CMIA) on the Alinity ci platform (Abbott Diagnostics). The study will be conducted in three phases: (1) participant recruitment and sample collection, (2) laboratory analysis and statistical evaluation using MedCalc software, and (3) preparation and publication of results in a peer-reviewed journal. The findings are expected to support more personalised and rational approaches to micronutrient supplementation in women planning pregnancy or who are already pregnant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes approximately 360 healthy women aged 18 to 49 years from the Herzegovina region who participate after providing written informed consent. All participants are being screened according to defined inclusion and exclusion criteria. The study focuses on assessing serum concentrations of vitamin B12, folic acid, and vitamin D to support the development of population-specific supplementation guidelines for the preconception period and pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of reproductive age (18-49 years)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* diabetes (Type I or II)\n* epilepsy\n* oncological diseases, inflammatory bowel disease\n* supplementation with vitamin B12, folic acid, or vitamin D within the last 3 months'}, 'identificationModule': {'nctId': 'NCT07100795', 'briefTitle': 'Vitamin B12, Folic Acid and Vitamin D Status in Women of Reproductive Age', 'organization': {'class': 'OTHER', 'fullName': 'University of Mostar'}, 'officialTitle': 'Assessment of Serum Concentrations of Vitamin B12, Folic Acid, and Vitamin D in Women of Reproductive Age to Determine Recommended Supplementation Doses in the Preconception Period and During Pregnancy', 'orgStudyIdInfo': {'id': 'SUM-VITB12-FOL-D3-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women of Reproductive Age', 'description': 'This cohort includes women aged 18 to 49 years who are undergoing blood sampling for analysis of serum concentrations of vitamin B12, folic acid, and vitamin D. No interventions are administered. This is an observational, cross-sectional study.', 'interventionNames': ['Other: No Interventions']}], 'interventions': [{'name': 'No Interventions', 'type': 'OTHER', 'description': 'This is an observational study. No intervention will be administered. Participants will provide blood samples for micronutrient analysis.', 'armGroupLabels': ['Women of Reproductive Age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88000', 'city': 'Mostar', 'status': 'RECRUITING', 'country': 'Bosnia and Herzegovina', 'contacts': [{'name': 'Vajdana Tomić, Professor, MD, Phd', 'role': 'CONTACT', 'email': 'vajdana.tomic@mef.sum.ba', 'phone': '0038763790012'}, {'name': 'Nikolina Penava, MD, Assistant', 'role': 'CONTACT', 'email': 'npenava@yahoo.com', 'phone': '0038763818875'}, {'name': 'Vajdana Tomić, Professor, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Clinical Hospital Mostar, Primary Health Care Center Mostar', 'geoPoint': {'lat': 43.34333, 'lon': 17.80806}}], 'centralContacts': [{'name': 'Vajdana Tomić, Professor, MD, PhD', 'role': 'CONTACT', 'email': 'vajdana.tomic@mef.sum.ba', 'phone': '0038763790012'}, {'name': 'Nikolina Penava, MD, Assistant', 'role': 'CONTACT', 'email': 'npenava@yahoo.com', 'phone': '0038763818875'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to privacy concerns and institutional policy limitations. All data will be analyzed and presented in aggregate form only, without identifying individual participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mostar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faculty of Health Studies - University of Mostar', 'class': 'UNKNOWN'}, {'name': 'Primary Health Care Center Mostar', 'class': 'UNKNOWN'}, {'name': 'University Clinical Hospital Mostar - Laboratory Department', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics and Gynecology; Principal Investigator', 'investigatorFullName': 'Professor Vajdana Tomić, MD, PhD', 'investigatorAffiliation': 'University of Mostar'}}}}