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

NCT07100795 | Recruiting

• 1 other identifier: SUM-VITB12-FOL-D3-2024
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Vitamin B12; Vitamin D; Folic acid

Outcome Measures

Primary Outcomes (3)

• Serum concentration of folic acid

  Measured in serum samples using Alinity i immunoassay system.

  At enrollment (single visit)

• Serum concentration of vitamin B12

  Measured in serum samples using Alinity i immunoassay system.

  At enrollment (single visit)

• Serum concentration of vitamin D

  Measured in serum samples using Alinity i immunoassay system.

  At enrollment (single visit)

Study Arms (1)

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.

Other: No Interventions

Interventions

No Interventions OTHER

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

Women of Reproductive Age

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mostar: lead
• Faculty of Health Studies - University of Mostar: collaborator
• Primary Health Care Center Mostar: collaborator
• University Clinical Hospital Mostar: collaborator

Study Sites (1)

University Clinical Hospital Mostar, Primary Health Care Center Mostar

Mostar, 88000, Bosnia and Herzegovina

RECRUITING

Central Study Contacts

Vajdana Tomić, Professor, MD, PhD

CONTACT

0038763790012; vajdana.tomic@mef.sum.ba

Nikolina Penava, MD, Assistant

CONTACT

0038763818875; npenava@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology; Principal Investigator

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)