An interventional study of Folic acid and iron supplementation and Control group in Nutrition Disorders, sponsored by Poznan University of Life Sciences. Completed at 1 site in Poland. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Poznan University of Life Sciences · Not applicable, Interventional, and Diagnostic
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.
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:
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.
Exclusion Criteria:
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
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
Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months
Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months
folic acid concentrations at baseline
blood folic acid concentrations at baseline
Time frame: At the baseline
folic acid concentrations after 3 months of treatment
blood folic acid concentrations after 3 months of treatment
Time frame: after 3 months of treatment
iron concentrations at baseline
blood iron concentrations at baseline
Time frame: At the baseline
iron concentrations after 3 months of treatment
blood ron concentrations after 3 months of treatment
Time frame: after 3 months of treatment
blood pressure
blood pressure
Time frame: At the baseline
body mass
body mass
Time frame: At the baseline
body height
body height
Time frame: At the baseline
Body % fat
Fat tissue % estimated with air displacement plethysmography
Time frame: At the baseline
Body % muscle
Muscle tissue % estimated with BodPod (air displacement plethysmography)
Time frame: At the baseline
ferritin at the baseline
serum ferritin concentration at the baseline
Time frame: At the baseline
ferritin after 3 months of treatment
serum ferritin concentration after 3 months of treatment
Time frame: after 3 months of treatment
hepcidin at the baseline
serum hepcidin concentration at the baseline
Time frame: At the baseline
hepcidin after 3 months of treatment
serum hepcidin concentration after 3 months of treatment
Time frame: after 3 months of treatment
homocysteine at the baseline
serum homocysteine concentration at the baseline
Time frame: At the baseline
homocysteine after 3 months of treatment
serum homocysteine concentration after 3 months of treatment
Time frame: after 3 months of treatment
total iron-binding capacity (TIBC) at the baseline
Blood total iron-binding capacity at the baseline
Time frame: At the baseline
TIBC after 3 months of treatment
Blood total iron-binding capacity after 3 months of treatment
Time frame: after 3 months of treatment
divalent metal transporter 1 (DMT1) gene polymorphisms
polymorphisms of gene encoding divalent metal transporter 1
Time frame: At the baseline
transferrin receptor 2 (TfR2) gene polymorphisms
polymorphisms of gene encoding transferrin receptor 2
Time frame: At the baseline
proton-coupled folate transporter (PCFT) gene polymorphisms
polymorphisms of gene encoding proton-coupled folate transporter
Time frame: At the baseline
reduced folate carrier (RFC) gene polymorphisms
polymorphisms of gene encoding reduced folate carrier
Time frame: At the baseline
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Poznan University of Life Sciences