The Study of the Influence of Intestinal and Cellular Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- folic acid concentrations at baseline
研究概览
简要总结
The aim of the study is to determine the factors affecting the bioavailability of iron and folic acid during the simultaneous use of iron supplements and folic acid supplements in non-pregnant women of childbearing age.
详细描述
Scientists in the field of nutrition and gynecology and obstetrics have been paying attention to the need of use iron and folate supplements in women of childbearing age. Increased intake of micronutrients in the diet or the use of supplementation does not always bring the expected results, what depends on factors that affect the bioavailability of minerals and vitamins. On the one hand these factors are related to the properties of food intake, e.g. to the presence of other nutrients that can increase or decrease the absorption of folates and iron (eg vitamin C, phytates), and on the other hand the functioning of the body itself, which to a certain extent is determined by genetic factors (e.g., genetically determined reduced activity of methylenetetrahydrofolate reductase [MTHFR], which reduces the bioavailability of folic acid).
The study aims:
-
assessment of the effect of simultaneous supplementation with iron and folate on:
-
parameters of the iron metabolism
-
parameters of the folate metabolism
-
the estimation of gene polymorphisms encoding proteins transporting iron and folate
-
obtaining information whether the polymorphism of genes encoding proteins transporting iron and folate is related to the effectiveness of the iron and folic acid supplementation used in non-pregnant women of childbearing age.
In 200 non-pregnant women of childbearing age a blood level of iron and folic acid will be determined. Subjects with low level of blood iron and folic acid will be supplemented with oral iron and folic acid for 3 months. Subjects with proper level of blood iron and folic acid will be a control group. At baseline and at completion of the study (after 3 months) fasting blood will be collected and abovementioned parameters will be estimated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18 to 35 years
- •stable body weight (< 3 kg self-reported change during the previous three months)
- •written informed consent to participate in the study,
- •regular menstrual period;
- •regular diet
排除标准
- •history of use of any dietary supplements within the one month prior to the study containing iron or folic acid
- •clinically relevant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis;
- •simultaneous participation in a study that affects body weight or use of diet / medication / nutritional behaviors affecting body weight;
- •a history of infection in the month prior to the study
- •nicotine, drug or alcohol abuse
- •vegetarian diet;
- •pregnancy or lactation
- •other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results
结局指标
主要结局
folic acid concentrations at baseline
时间窗: At the baseline
blood folic acid concentrations at baseline
iron concentrations at baseline
时间窗: At the baseline
blood iron concentrations at baseline
folic acid concentrations after 3 months of treatment
时间窗: after 3 months of treatment
blood folic acid concentrations after 3 months of treatment
iron concentrations after 3 months of treatment
时间窗: after 3 months of treatment
blood ron concentrations after 3 months of treatment
次要结局
- blood pressure(At the baseline)
- Body % muscle(At the baseline)
- hepcidin at the baseline(At the baseline)
- ferritin at the baseline(At the baseline)
- body height(At the baseline)
- ferritin after 3 months of treatment(after 3 months of treatment)
- total iron-binding capacity (TIBC) at the baseline(At the baseline)
- reduced folate carrier (RFC) gene polymorphisms(At the baseline)
- Body % fat(At the baseline)
- divalent metal transporter 1 (DMT1) gene polymorphisms(At the baseline)
- transferrin receptor 2 (TfR2) gene polymorphisms(At the baseline)
- body mass(At the baseline)
- hepcidin after 3 months of treatment(after 3 months of treatment)
- homocysteine at the baseline(At the baseline)
- TIBC after 3 months of treatment(after 3 months of treatment)
- homocysteine after 3 months of treatment(after 3 months of treatment)
- proton-coupled folate transporter (PCFT) gene polymorphisms(At the baseline)
研究者
Joanna Suliburska
assistant professor
Poznan University of Life Sciences