Clinical trial NCT03438942: Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
Official title: The Study of the Influence of Intestinal and Cellular Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders
Keywords: iron
folate
childbearing age
bioavailability
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: folic acid concentrations at baseline
timeFrame: At the baseline
measure: folic acid concentrations after 3 months of treatment
timeFrame: after 3 months of treatment
measure: iron concentrations at baseline
timeFrame: At the baseline
measure: iron concentrations after 3 months of treatment
timeFrame: after 3 months of treatment
Secondary outcomes:
measure: blood pressure
timeFrame: At the baseline
measure: body mass
timeFrame: At the baseline
measure: body height
timeFrame: At the baseline
measure: Body % fat
timeFrame: At the baseline
measure: Body % muscle
timeFrame: At the baseline
measure: ferritin at the baseline
timeFrame: At the baseline
measure: ferritin after 3 months of treatment
timeFrame: after 3 months of treatment
measure: hepcidin at the baseline
timeFrame: At the baseline
measure: hepcidin after 3 months of treatment
timeFrame: after 3 months of treatment
measure: homocysteine at the baseline
timeFrame: At the baseline
measure: homocysteine after 3 months of treatment
timeFrame: after 3 months of treatment
measure: total iron-binding capacity (TIBC) at the baseline
timeFrame: At the baseline
measure: TIBC after 3 months of treatment
timeFrame: after 3 months of treatment
measure: divalent metal transporter 1 (DMT1) gene polymorphisms
timeFrame: At the baseline
measure: transferrin receptor 2 (TfR2) gene polymorphisms
timeFrame: At the baseline
measure: proton-coupled folate transporter (PCFT) gene polymorphisms
timeFrame: At the baseline
measure: reduced folate carrier (RFC) gene polymorphisms
timeFrame: At the baseline
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences
name: Joanna Suliburska, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: