Vitamin B12, Folic Acid, and Vitamin D Status in Women of Reproductive Age

NCT ID: NCT07099586

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-12-01

Brief Summary

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.

The study will be conducted at the Faculty of Health Studies, University of Mostar, Bosnia and Herzegovina.

Detailed Description

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.

This 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.

A 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.

.

Conditions

Vitamin d, Vitamin B 12 and Folic Acid Concentrations; Micronutrient Status in Women of Reproductive Age; Vitamin Status Assessment

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Women of Reproductive Age

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.

No Interventions

Intervention Type: OTHER

This is an observational study. No intervention will be administered. Participants will provide blood samples for micronutrient analysis.

Interventions

No Interventions

This is an observational study. No intervention will be administered. Participants will provide blood samples for micronutrient analysis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women of reproductive age (18-49 years)
• Informed consent obtained

Exclusion Criteria

• diabetes (Type I or II)
• epilepsy
• oncological diseases, inflammatory bowel disease
• supplementation with vitamin B12, folic acid, or vitamin D within the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Mostar

OTHER

Sponsor Role: lead

Responsible Party

Nikolina Penava

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Mostar

Mostar, , Bosnia and Herzegovina

Site Status: RECRUITING

Countries

Bosnia and Herzegovina

Central Contacts

Vajdana Tomić, professor, MD

Role: CONTACT

vajdana.tomic@mef.sum.ba

063790012

Facility Contacts

Vajdana Tomić, professor, MD

Role: primary

vajdana.tomic@mef.sum.ba

063790012

Nikolina Penava, MD

Role: backup

npenava@yahoo.com

Other Identifiers

SUM-VITB12-FOL-D-2024

Identifier Type: -

Identifier Source: org_study_id