Nutrition DisordersWiMKoNCT03438942
Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
A study testing Folic acid and iron supplementation in people with Nutrition Disorders, run by Poznan University of Life Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Folic acid and iron supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 30 Sep 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition Disorders
- Being tested
- Folic acid and iron supplementation, Control group
- Keywords
- iron, folate, childbearing age, bioavailability
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acid and iron supplementationDietary supplement
Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months
Control groupDietary supplement
Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Folic acid and iron supplementation | Experimental | Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months Receives: Dietary Supplement: Folic acid and iron supplementation |
| Control group | Active comparator | Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
folic acid concentrations at baseline
blood folic acid concentrations at baseline
Measured: At the baseline
folic acid concentrations after 3 months of treatment
blood folic acid concentrations after 3 months of treatment
Measured: after 3 months of treatment
iron concentrations at baseline
blood iron concentrations at baseline
Measured: At the baseline
iron concentrations after 3 months of treatment
blood ron concentrations after 3 months of treatment
Measured: after 3 months of treatment
Secondary outcomes (17)
blood pressure
blood pressure
Measured: At the baseline
body mass
body mass
Measured: At the baseline
body height
body height
Measured: At the baseline
Body % fat
Fat tissue % estimated with air displacement plethysmography
Measured: At the baseline
Body % muscle
Muscle tissue % estimated with BodPod (air displacement plethysmography)
Measured: At the baseline
ferritin at the baseline
serum ferritin concentration at the baseline
Measured: At the baseline
ferritin after 3 months of treatment
serum ferritin concentration after 3 months of treatment
Measured: after 3 months of treatment
hepcidin at the baseline
serum hepcidin concentration at the baseline
Measured: At the baseline
hepcidin after 3 months of treatment
serum hepcidin concentration after 3 months of treatment
Measured: after 3 months of treatment
homocysteine at the baseline
serum homocysteine concentration at the baseline
Measured: At the baseline
homocysteine after 3 months of treatment
serum homocysteine concentration after 3 months of treatment
Measured: after 3 months of treatment
total iron-binding capacity (TIBC) at the baseline
Blood total iron-binding capacity at the baseline
Measured: At the baseline
TIBC after 3 months of treatment
Blood total iron-binding capacity after 3 months of treatment
Measured: after 3 months of treatment
divalent metal transporter 1 (DMT1) gene polymorphisms
polymorphisms of gene encoding divalent metal transporter 1
Measured: At the baseline
transferrin receptor 2 (TfR2) gene polymorphisms
polymorphisms of gene encoding transferrin receptor 2
Measured: At the baseline
proton-coupled folate transporter (PCFT) gene polymorphisms
polymorphisms of gene encoding proton-coupled folate transporter
Measured: At the baseline
reduced folate carrier (RFC) gene polymorphisms
polymorphisms of gene encoding reduced folate carrier
Measured: At the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start30 Sep 2018
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Suliburska, Poznan University of Life Sciences
- Investigators
- Joanna Suliburska, Ass Prof, Principal investigator, Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438942
- Sponsor's protocol ID
- 917/16
- Acronym
- WiMKo
- Status last verified
- Apr 2022
- First submitted
- 13 Feb 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of the Influence of Intestinal and Cellular Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism
- ClinicalTrials.gov ID
- NCT03438942
- Acronym / sponsor ID
- WiMKo / 917/16
- Conditions
- Nutrition Disorders
- Keywords
- iron, folate, childbearing age, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid and iron supplementation | Experimental | Dietary Supplement: Folic acid and iron supplementationIndividuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months |
| Control group | Active comparator | Dietary Supplement: Control groupIndividuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acid and iron supplementationIndividuals 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 |
| Control groupIndividuals 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 |
Primary outcome
folic acid concentrations at baseline
Time frame: At the baseline
blood folic acid concentrations at baseline
folic acid concentrations after 3 months of treatment
Time frame: after 3 months of treatment
blood folic acid concentrations after 3 months of treatment
iron concentrations at baseline
Time frame: At the baseline
blood iron concentrations at baseline
iron concentrations after 3 months of treatment
Time frame: after 3 months of treatment
blood ron concentrations after 3 months of treatment
17 secondary outcomes
blood pressure
Time frame: At the baseline
body mass
Time frame: At the baseline
body height
Time frame: At the baseline
Body % fat
Time frame: At the baseline
Body % muscle
Time frame: At the baseline
ferritin at the baseline
Time frame: At the baseline
ferritin after 3 months of treatment
Time frame: after 3 months of treatment
hepcidin at the baseline
Time frame: At the baseline
hepcidin after 3 months of treatment
Time frame: after 3 months of treatment
homocysteine at the baseline
Time frame: At the baseline
homocysteine after 3 months of treatment
Time frame: after 3 months of treatment
total iron-binding capacity (TIBC) at the baseline
Time frame: At the baseline
TIBC after 3 months of treatment
Time frame: after 3 months of treatment
divalent metal transporter 1 (DMT1) gene polymorphisms
Time frame: At the baseline
transferrin receptor 2 (TfR2) gene polymorphisms
Time frame: At the baseline
proton-coupled folate transporter (PCFT) gene polymorphisms
Time frame: At the baseline
reduced folate carrier (RFC) gene polymorphisms
Time frame: At the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Suliburska, Ass Prof principal investigator
Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid and iron supplementation in people with Nutrition Disorders, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
folic acid concentrations at baseline (time frame: At the baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.