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临床试验/NCT07100795
NCT07100795招募中不适用

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

University of Mostar2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年12月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
2
主要终点
Serum concentration of vitamin B12

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: No Interventions (Other)

结局指标

主要结局

Serum concentration of vitamin B12

时间窗: At enrollment (single visit)

Measured in serum samples using Alinity i immunoassay system.

Serum concentration of folic acid

时间窗: At enrollment (single visit)

Measured in serum samples using Alinity i immunoassay system.

Serum concentration of vitamin D

时间窗: At enrollment (single visit)

Measured in serum samples using Alinity i immunoassay system.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Vajdana Tomić, MD, PhD

Professor of Obstetrics and Gynecology; Principal Investigator

University of Mostar

研究点 (2)

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