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

The Study of the Influence of Intestinal and Cellular 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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders
• Intervention / Treatment: Dietary supplement: Folic acid and iron supplementation; Dietary supplement: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland, 60-624
    • Poznan University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Folic 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 supplement: Folic 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
Active Comparator: Control group; 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 proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Investigators: Principal Investigator: Joanna Suliburska, Ass Prof, Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 18, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: bioavailability; iron; folate; childbearing age
• Additional Relevant MeSH Terms: Nutrition Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: 917/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No