Vitamin D, Vitamin B 12 and Folic Acid ConcentrationsNCT07100795
Vitamin B12, Folic Acid and Vitamin D Status in Women of Reproductive Age
An observational study of Vitamin D, Vitamin B 12 and Folic Acid Concentrations and Micronutrient Status in Women of Reproductive Age, run by University of Mostar at 1 site in Bosnia and Herzegovina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D, Vitamin B 12 and Folic Acid Concentrations, Micronutrient Status in Women of Reproductive Age, Vitamin Status Assessment
- How many people
- 360 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 23 Dec 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Women of reproductive age (18-49 years)
- Informed consent obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
University Clinical Hospital Mostar, Primary Health Care Center Mostar
Mostar, 88000
Vajdana Tomić, Professor, MD, Phd, 0038763790012, vajdana.tomic@mef.sum.ba
Nikolina Penava, MD, Assistant, 0038763818875, npenava@yahoo.com
About this study
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
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.
Read the 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
- Being tested
- No Interventions
- Keywords
- Vitamin B12, Vitamin D, Folic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
This is an observational study. No intervention will be administered. Participants will provide blood samples for micronutrient analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of folic acid
Measured in serum samples using Alinity i immunoassay system.
Measured: At enrollment (single visit)
Serum concentration of vitamin B12
Measured in serum samples using Alinity i immunoassay system.
Measured: At enrollment (single visit)
Serum concentration of vitamin D
Measured in serum samples using Alinity i immunoassay system.
Measured: At enrollment (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start23 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D, Vitamin B 12 and Folic Acid ConcentrationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Health Studies - University of Mostar, Primary Health Care Center Mostar, University Clinical Hospital Mostar
- Responsible party
- Principal investigator, Professor Vajdana Tomić, MD, PhD, University of Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100795
- Sponsor's protocol ID
- SUM-VITB12-FOL-D3-2024
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07100795
- Acronym / sponsor ID
- SUM-VITB12-FOL-D3-2024
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Collaborators
- Faculty of Health Studies - University of Mostar, Primary Health Care Center Mostar, University Clinical Hospital Mostar
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women of Reproductive Age | – | Other: No InterventionsThis 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Women of reproductive age (18-49 years)
- Informed consent obtained
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsThis is an observational study. No intervention will be administered. Participants will provide blood samples for micronutrient analysis. | Other | Women of Reproductive Age |
Primary outcome
Serum concentration of folic acid
Time frame: At enrollment (single visit)
Measured in serum samples using Alinity i immunoassay system.
Serum concentration of vitamin B12
Time frame: At enrollment (single visit)
Measured in serum samples using Alinity i immunoassay system.
Serum concentration of vitamin D
Time frame: At enrollment (single visit)
Measured in serum samples using Alinity i immunoassay system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D, Vitamin B 12 and Folic Acid Concentrations and Micronutrient Status in Women of Reproductive Age, run by University of Mostar at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vajdana Tomić, Professor, MD, PhD (0038763790012, vajdana.tomic@mef.sum.ba), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of folic acid (time frame: At enrollment (single visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.