Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Study of the Influence of Intestinal and Cellular Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism

Conditions
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Nutrition Disorders

Intervention / Treatment
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* Dietary Supplement: Folic acid and iron supplementation
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Folic acid and iron supplementation<br>Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months | Dietary Supplement: Folic acid and iron supplementation<br>* Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months<br>|
| Active Comparator: Control group<br>Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months | Dietary Supplement: Control group<br>* Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| folic acid concentrations at baseline | blood folic acid concentrations at baseline | At the baseline | 
| folic acid concentrations after 3 months of treatment | blood folic acid concentrations after 3 months of treatment | after 3 months of treatment | 
| iron concentrations at baseline | blood iron concentrations at baseline | At the baseline | 
| iron concentrations after 3 months of treatment | blood ron concentrations after 3 months of treatment | after 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | blood pressure | At the baseline | 
| body mass | body mass | At the baseline | 
| body height | body height | At the baseline | 
| Body % fat | Fat tissue % estimated with air displacement plethysmography | At the baseline | 
| Body % muscle | Muscle tissue % estimated with BodPod (air displacement plethysmography) | At the baseline | 
| ferritin at the baseline | serum ferritin concentration at the baseline | At the baseline | 
| ferritin after 3 months of treatment | serum ferritin concentration after 3 months of treatment | after 3 months of treatment | 
| hepcidin at the baseline | serum hepcidin concentration at the baseline | At the baseline | 
| hepcidin after 3 months of treatment | serum hepcidin concentration after 3 months of treatment | after 3 months of treatment | 
| homocysteine at the baseline | serum homocysteine concentration at the baseline | At the baseline | 
| homocysteine after 3 months of treatment | serum homocysteine concentration after 3 months of treatment | after 3 months of treatment | 
| total iron-binding capacity (TIBC) at the baseline | Blood total iron-binding capacity at the baseline | At the baseline | 
| TIBC after 3 months of treatment | Blood total iron-binding capacity after 3 months of treatment | after 3 months of treatment | 
| divalent metal transporter 1 (DMT1) gene polymorphisms | polymorphisms of gene encoding divalent metal transporter 1 | At the baseline | 
| transferrin receptor 2 (TfR2) gene polymorphisms | polymorphisms of gene encoding transferrin receptor 2 | At the baseline | 
| proton-coupled folate transporter (PCFT) gene polymorphisms | polymorphisms of gene encoding proton-coupled folate transporter | At the baseline | 
| reduced folate carrier (RFC) gene polymorphisms | polymorphisms of gene encoding reduced folate carrier | At the baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, folate, childbearing age, bioavailability