Vitamin B12, Folic Acid, and Vitamin D Status in Women of Reproductive Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Interventions.
- Who it may be relevant to
- Registry conditions: Vitamin d, Vitamin B 12 and Folic Acid Concentrations, Micronutrient Status in Women of Reproductive Age, Vitamin Status Assessment. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bosnia and Herzegovina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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Interventions
- Other No Interventions
This is an observational study. No intervention will be administered. Participants will provide blood samples for micronutrient analysis.
Primary outcome measures
- Serum concentration of vitamin B12 [Time frame: At enrollment (single visit)]
- Serum concentration of folic acid [Time frame: At enrollment (single visit)]
- Serum concentration of vitamin D [Time frame: At enrollment (single visit)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Bosnia and Herzegovina · 1 center
- University Hospital Mostar — Mostar
Identifiers
NCT: NCT07099586 · SUM-VITB12-FOL-D-2024