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Completed

NCT Number: NCT03438942

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Life Sciences

Poznan, 60-624, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic acid and iron supplementation

Dietary Supplement

Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months

Control group

Dietary Supplement

Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months

Primary outcomes

  1. folic acid concentrations at baseline

    Time frame: At the baseline

    blood folic acid concentrations at baseline

  2. folic acid concentrations after 3 months of treatment

    Time frame: after 3 months of treatment

    blood folic acid concentrations after 3 months of treatment

  3. iron concentrations at baseline

    Time frame: At the baseline

    blood iron concentrations at baseline

  4. iron concentrations after 3 months of treatment

    Time frame: after 3 months of treatment

    blood ron concentrations after 3 months of treatment

Secondary outcomes

  1. blood pressure

    Time frame: At the baseline

    blood pressure

  2. body mass

    Time frame: At the baseline

    body mass

  3. body height

    Time frame: At the baseline

    body height

  4. Body % fat

    Time frame: At the baseline

    Fat tissue % estimated with air displacement plethysmography

  5. Body % muscle

    Time frame: At the baseline

    Muscle tissue % estimated with BodPod (air displacement plethysmography)

  6. ferritin at the baseline

    Time frame: At the baseline

    serum ferritin concentration at the baseline

  7. ferritin after 3 months of treatment

    Time frame: after 3 months of treatment

    serum ferritin concentration after 3 months of treatment

  8. hepcidin at the baseline

    Time frame: At the baseline

    serum hepcidin concentration at the baseline

  9. hepcidin after 3 months of treatment

    Time frame: after 3 months of treatment

    serum hepcidin concentration after 3 months of treatment

  10. homocysteine at the baseline

    Time frame: At the baseline

    serum homocysteine concentration at the baseline

  11. homocysteine after 3 months of treatment

    Time frame: after 3 months of treatment

    serum homocysteine concentration after 3 months of treatment

  12. total iron-binding capacity (TIBC) at the baseline

    Time frame: At the baseline

    Blood total iron-binding capacity at the baseline

  13. TIBC after 3 months of treatment

    Time frame: after 3 months of treatment

    Blood total iron-binding capacity after 3 months of treatment

  14. divalent metal transporter 1 (DMT1) gene polymorphisms

    Time frame: At the baseline

    polymorphisms of gene encoding divalent metal transporter 1

  15. transferrin receptor 2 (TfR2) gene polymorphisms

    Time frame: At the baseline

    polymorphisms of gene encoding transferrin receptor 2

  16. proton-coupled folate transporter (PCFT) gene polymorphisms

    Time frame: At the baseline

    polymorphisms of gene encoding proton-coupled folate transporter

  17. reduced folate carrier (RFC) gene polymorphisms

    Time frame: At the baseline

    polymorphisms of gene encoding reduced folate carrier

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Registry information

Official study title

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

Acronym: WiMKo

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2018
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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