Nutrition Disorders
Conditions
Keywords
iron, folate, childbearing age, bioavailability
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTFolic acid and iron supplementation
Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months
DIETARY_SUPPLEMENTControl group
Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months
Sponsors
Poznan University of Life Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| folic acid concentrations at baseline | At the baseline | blood folic acid concentrations at baseline |
| folic acid concentrations after 3 months of treatment | after 3 months of treatment | blood folic acid concentrations after 3 months of treatment |
| iron concentrations at baseline | At the baseline | blood iron concentrations at baseline |
| iron concentrations after 3 months of treatment | after 3 months of treatment | blood ron concentrations after 3 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body % muscle | At the baseline | Muscle tissue % estimated with BodPod (air displacement plethysmography) |
| ferritin at the baseline | At the baseline | serum ferritin concentration at the baseline |
| ferritin after 3 months of treatment | after 3 months of treatment | serum ferritin concentration after 3 months of treatment |
| hepcidin at the baseline | At the baseline | serum hepcidin concentration at the baseline |
| total iron-binding capacity (TIBC) at the baseline | At the baseline | Blood total iron-binding capacity at the baseline |
| hepcidin after 3 months of treatment | after 3 months of treatment | serum hepcidin concentration after 3 months of treatment |
| blood pressure | At the baseline | blood pressure |
| homocysteine after 3 months of treatment | after 3 months of treatment | serum homocysteine concentration after 3 months of treatment |
| TIBC after 3 months of treatment | after 3 months of treatment | Blood total iron-binding capacity after 3 months of treatment |
| divalent metal transporter 1 (DMT1) gene polymorphisms | At the baseline | polymorphisms of gene encoding divalent metal transporter 1 |
| transferrin receptor 2 (TfR2) gene polymorphisms | At the baseline | polymorphisms of gene encoding transferrin receptor 2 |
| proton-coupled folate transporter (PCFT) gene polymorphisms | At the baseline | polymorphisms of gene encoding proton-coupled folate transporter |
| reduced folate carrier (RFC) gene polymorphisms | At the baseline | polymorphisms of gene encoding reduced folate carrier |
| homocysteine at the baseline | At the baseline | serum homocysteine concentration at the baseline |
| body mass | At the baseline | body mass |
| body height | At the baseline | body height |
| Body % fat | At the baseline | Fat tissue % estimated with air displacement plethysmography |
Countries
Poland
Outcome results
None listed