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

Sponsor

Poznan University of Life Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03438942

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition Disorders	Dietary Supplement: Folic acid and iron supplementation Dietary Supplement: Control group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 30, 2018

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

blood pressure [At the baseline]
blood pressure
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
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
hepcidin after 3 months of treatment [after 3 months of treatment]
serum hepcidin concentration after 3 months of treatment
homocysteine at the baseline [At the baseline]
serum homocysteine concentration at the baseline
homocysteine after 3 months of treatment [after 3 months of treatment]
serum homocysteine concentration after 3 months of treatment
total iron-binding capacity (TIBC) at the baseline [At the baseline]
Blood total iron-binding capacity at the baseline
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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