Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism (WiMKo)
Primary Purpose
Nutrition Disorders
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Folic acid and iron supplementation
Control group
Sponsored by
About this trial
This is an interventional diagnostic trial for Nutrition Disorders focused on measuring iron, folate, childbearing age, bioavailability
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
Sites / Locations
- Poznan University of Life Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Folic acid and iron supplementation
Control group
Arm Description
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
Outcomes
Primary Outcome Measures
folic acid concentrations at baseline
blood folic acid concentrations at baseline
folic acid concentrations after 3 months of treatment
blood folic acid concentrations after 3 months of treatment
iron concentrations at baseline
blood iron concentrations at baseline
iron concentrations after 3 months of treatment
blood ron concentrations after 3 months of treatment
Secondary Outcome Measures
blood pressure
blood pressure
body mass
body mass
body height
body height
Body % fat
Fat tissue % estimated with air displacement plethysmography
Body % muscle
Muscle tissue % estimated with BodPod (air displacement plethysmography)
ferritin at the baseline
serum ferritin concentration at the baseline
ferritin after 3 months of treatment
serum ferritin concentration after 3 months of treatment
hepcidin at the baseline
serum hepcidin concentration at the baseline
hepcidin after 3 months of treatment
serum hepcidin concentration after 3 months of treatment
homocysteine at the baseline
serum homocysteine concentration at the baseline
homocysteine after 3 months of treatment
serum homocysteine concentration after 3 months of treatment
total iron-binding capacity (TIBC) at the baseline
Blood total iron-binding capacity at the baseline
TIBC after 3 months of treatment
Blood total iron-binding capacity after 3 months of treatment
divalent metal transporter 1 (DMT1) gene polymorphisms
polymorphisms of gene encoding divalent metal transporter 1
transferrin receptor 2 (TfR2) gene polymorphisms
polymorphisms of gene encoding transferrin receptor 2
proton-coupled folate transporter (PCFT) gene polymorphisms
polymorphisms of gene encoding proton-coupled folate transporter
reduced folate carrier (RFC) gene polymorphisms
polymorphisms of gene encoding reduced folate carrier
Full Information
NCT ID
NCT03438942
First Posted
February 13, 2018
Last Updated
April 4, 2022
Sponsor
Poznan University of Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03438942
Brief Title
Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
Acronym
WiMKo
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Life Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
Keywords
iron, folate, childbearing age, bioavailability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Folic acid and iron supplementation
Arm Type
Experimental
Arm Description
Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic acid and iron supplementation
Intervention Description
Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group
Intervention Description
Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months
Primary Outcome Measure Information:
Title
folic acid concentrations at baseline
Description
blood folic acid concentrations at baseline
Time Frame
At the baseline
Title
folic acid concentrations after 3 months of treatment
Description
blood folic acid concentrations after 3 months of treatment
Time Frame
after 3 months of treatment
Title
iron concentrations at baseline
Description
blood iron concentrations at baseline
Time Frame
At the baseline
Title
iron concentrations after 3 months of treatment
Description
blood ron concentrations after 3 months of treatment
Time Frame
after 3 months of treatment
Secondary Outcome Measure Information:
Title
blood pressure
Description
blood pressure
Time Frame
At the baseline
Title
body mass
Description
body mass
Time Frame
At the baseline
Title
body height
Description
body height
Time Frame
At the baseline
Title
Body % fat
Description
Fat tissue % estimated with air displacement plethysmography
Time Frame
At the baseline
Title
Body % muscle
Description
Muscle tissue % estimated with BodPod (air displacement plethysmography)
Time Frame
At the baseline
Title
ferritin at the baseline
Description
serum ferritin concentration at the baseline
Time Frame
At the baseline
Title
ferritin after 3 months of treatment
Description
serum ferritin concentration after 3 months of treatment
Time Frame
after 3 months of treatment
Title
hepcidin at the baseline
Description
serum hepcidin concentration at the baseline
Time Frame
At the baseline
Title
hepcidin after 3 months of treatment
Description
serum hepcidin concentration after 3 months of treatment
Time Frame
after 3 months of treatment
Title
homocysteine at the baseline
Description
serum homocysteine concentration at the baseline
Time Frame
At the baseline
Title
homocysteine after 3 months of treatment
Description
serum homocysteine concentration after 3 months of treatment
Time Frame
after 3 months of treatment
Title
total iron-binding capacity (TIBC) at the baseline
Description
Blood total iron-binding capacity at the baseline
Time Frame
At the baseline
Title
TIBC after 3 months of treatment
Description
Blood total iron-binding capacity after 3 months of treatment
Time Frame
after 3 months of treatment
Title
divalent metal transporter 1 (DMT1) gene polymorphisms
Description
polymorphisms of gene encoding divalent metal transporter 1
Time Frame
At the baseline
Title
transferrin receptor 2 (TfR2) gene polymorphisms
Description
polymorphisms of gene encoding transferrin receptor 2
Time Frame
At the baseline
Title
proton-coupled folate transporter (PCFT) gene polymorphisms
Description
polymorphisms of gene encoding proton-coupled folate transporter
Time Frame
At the baseline
Title
reduced folate carrier (RFC) gene polymorphisms
Description
polymorphisms of gene encoding reduced folate carrier
Time Frame
At the baseline
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female gender based on self-representation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Suliburska, Ass Prof
Organizational Affiliation
Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poznan University of Life Sciences
City
Poznań
ZIP/Postal Code
60-624
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
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