Well BeingFe-HealthNCT06648018
Comparison of Nutritional Information With Iron-succinate Supplementation in Healthy Women
A study testing Nutritional information and Iron-succinate in people with Well Being, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years for 8 weeks. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Well Being
- What is being tested?
- Nutritional information and Iron-succinate
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 15 Oct 2024to Jan 2025
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria: Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise.
-
Exclusion Criteria: Significant disease affecting inflammation and/or hemoglobin levels. Inability to cooperate or to fill out questionnaires.
-
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Faculty of Medicine and Health Sciences Linköping University
Linköping, 58185
About this study
Official title: Fe-minine Health and Exercise
The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years for 8 weeks. The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system. Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate. Study parameters are blood tests (fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP) and Body height and weight as well as questionnaires.
Read the detailed description
Aim The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years.
Methods The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system.
Recruitment and participation criteria Individuals will be recruited through any or all of the following: at primary care center(s) in Sweden, via posters at the care center(s), via care providers during visits to the care center(s) and/or via external advertisement through social media and/or at public spaces.
Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise. As reimbursement, participants will receive 2000 SEK for the drawing of blood samples at the end of their study participation.
Inclusion visit
Individuals interested to participate will be booked for an inclusion visit with a study nurse during which oral and written information of the study will be provided, and a written consent will be given. Online, participants will then be asked to fill in the following information:
- A detailed online questionnaire regarding age, use of nicotine and tobacco products, and any drugs or supplements.
- A questionnaire on menstruation quantities including the number of menstruation days, the number of heavy menstruation days, and the menstrual product use, which has been shown to accurately estimate menstrual blood loss.24
- The Alcohol use disorders identification test (AUDIT)
- A food frequency questionnaire (FFQ)
- To evaluate physical activity, we will use the validated questions from the Swedish National Board of Health and Welfare,25 as well as the validated SED-GIH question of The Swedish School of Sport and Health Sciences (GIH) on sedentary behavior which was also developed with support from the Swedish National Board of Health and Welfare.26
- A questionnaire on gastrointestinal symptoms, including the number of bowel movements per week and the quality of them assessed using the Bristol stool scale (BSS). Gastrointestinal transit time can be approximated as defecation frequency, or more accurately, as stool consistency 27, and the BSS is one such questionnaire.
Body height and weight, with participants in light clothing without shoes, as well as fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP).
Intervention/control period Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate.
Conclusion visit Of the above information, the following will be repeated after the conclusion of the 8 week intervention/control period: questionnaires on physical activity and gastrointestinal symptoms, the FFQ, and the drawing of blood samples.
- Conditions
- Well Being
- Being tested
- Nutritional information, Iron-succinate
- Keywords
- nutrition, exercise, iron, well being
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional informationBehavioural
Written nutritional information about food with high content of iron.
Iron-succinateDietary supplement
100 mg of Iron-succinate per day.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional information | Active comparator | Written information about food with high iron content. Receives: Behavioral: Nutritional information |
| 100mg iron-succinate per day as a pill. | Experimental | Participants get 56 pills of 100mg iron-succinate to take one/day for 8 weeks. Receives: Dietary Supplement: Iron-succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin blood test
Change (increase) in serum ferritin levels.
Measured: From enrollment to end of test period, 8 weeks.
Secondary outcomes (2)
Changes in measures of hemoglobin
Changes in measures of hemoglobin levels by blood tests
Measured: From enrollment to end of test period, 8 weeks.
Sense of well being and subjective sense of health
Sense of well being and subjective sense of health by questionnaires at start and baseline
Measured: From enrollment to end of test period, 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well BeingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Primary Health Care Center, Region Östergötland, Linkoeping University
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
- Investigators
- Fredrik H Nyström, MD PhD Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648018
- Sponsor's protocol ID
- Fe-minine health and exercise
- Acronym
- Fe-Health
- Status last verified
- Oct 2024
- First submitted
- 15 Sep 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For ethical reasons such data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fe-minine Health and Exercise
- ClinicalTrials.gov ID
- NCT06648018
- Acronym / sponsor ID
- Fe-Health / Fe-minine health and exercise
- Conditions
- Well Being
- Keywords
- nutrition, exercise, iron, well being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Primary Health Care Center, Region Östergötland, Linkoeping University
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Oct 2024 (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 primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years for 8 weeks. The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system. Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate. Study parameters are blood tests (fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP) and Body height and weight as well as questionnaires.
Detailed description
Aim The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years.
Methods The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system.
Recruitment and participation criteria Individuals will be recruited through any or all of the following: at primary care center(s) in Sweden, via posters at the care center(s), via care providers during visits to the care center(s) and/or via external advertisement through social media and/or at public spaces.
Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise. As reimbursement, participants will receive 2000 SEK for the drawing of blood samples at the end of their study participation.
Inclusion visit
Individuals interested to participate will be booked for an inclusion visit with a study nurse during which oral and written information of the study will be provided, and a written consent will be given. Online, participants will then be asked to fill in the following information:
- A detailed online questionnaire regarding age, use of nicotine and tobacco products, and any drugs or supplements.
- A questionnaire on menstruation quantities including the number of menstruation days, the number of heavy menstruation days, and the menstrual product use, which has been shown to accurately estimate menstrual blood loss.24
- The Alcohol use disorders identification test (AUDIT)
- A food frequency questionnaire (FFQ)
- To evaluate physical activity, we will use the validated questions from the Swedish National Board of Health and Welfare,25 as well as the validated SED-GIH question of The Swedish School of Sport and Health Sciences (GIH) on sedentary behavior which was also developed with support from the Swedish National Board of Health and Welfare.26
- A questionnaire on gastrointestinal symptoms, including the number of bowel movements per week and the quality of them assessed using the Bristol stool scale (BSS). Gastrointestinal transit time can be approximated as defecation frequency, or more accurately, as stool consistency 27, and the BSS is one such questionnaire.
Body height and weight, with participants in light clothing without shoes, as well as fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP).
Intervention/control period Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate.
Conclusion visit Of the above information, the following will be repeated after the conclusion of the 8 week intervention/control period: questionnaires on physical activity and gastrointestinal symptoms, the FFQ, and the drawing of blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional information | Active comparator | Behavioral: Nutritional informationWritten information about food with high iron content. |
| 100mg iron-succinate per day as a pill. | Experimental | Dietary Supplement: Iron-succinateParticipants get 56 pills of 100mg iron-succinate to take one/day for 8 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Nutritional informationWritten nutritional information about food with high content of iron. | Behavioural | Nutritional information |
| Iron-succinate100 mg of Iron-succinate per day. | Dietary supplement | 100mg iron-succinate per day as a pill. |
Primary outcome
Ferritin blood test
Time frame: From enrollment to end of test period, 8 weeks.
Change (increase) in serum ferritin levels.
2 secondary outcomes
Changes in measures of hemoglobin
Time frame: From enrollment to end of test period, 8 weeks.
Sense of well being and subjective sense of health
Time frame: From enrollment to end of test period, 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No. For ethical reasons such data will not be shared.
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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.
Fredrik H Nyström, MD PhD Professor principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional information and Iron-succinate in people with Well Being, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 18 Oct 2024. 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 Sweden. 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?
Results are not available in the source record.
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?
Ferritin blood test (time frame: From enrollment to end of test period, 8 weeks.). 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 18 Oct 2024.