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

Recruiting

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

• Registration Number: NCT07099586
• Lead Sponsor: University of Mostar

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.

.

Study Timeline

• Study Start: 2024-12-20
• Status Verified: 2025-07
• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum concentration of vitamin B12	At enrollment (single visit)	Measured in serum samples using Alinity i immunoassay system.
Serum concentration of folic acid	At enrollment (single visit)	Measured in serum samples using Alinity i immunoassay system.
Serum concentration of vitamin D	At enrollment (single visit)	Measured in serum samples using Alinity i immunoassay system.

Trial Locations

Locations (1)

University Hospital Mostar; 🇧🇦 Mostar, Bosnia and Herzegovina