Iron DeficiencyNCT02177851
The Optimization of Bioavailability From Iron Supplements: Study 2
A study testing Single oral iron dose of 120 mg per day for 3 consecutive days and Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days in people with Iron Deficiency and Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anemia, Iron Deficiency Anemia
- What is being tested?
- Single oral iron dose of 120 mg per day for 3 consecutive days and Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Dec 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18 to 45 years old,
- Serum Ferritin levels <20 µg/L,
- Normal body Mass Index (18.5-25 kg/m2),
- Body weight <65 kg,
- Signed informed consent
Who cannot join
- Anaemia (Hb < 11.7 g/dL),
- Elevated c-reactive protein or alpha1 glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively,
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
- Continuous/long-term use of medication during the whole studies (except for contraceptives),
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration,
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months,
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- Earlier participation in a study using stable iron isotopes,
- Known hypersensitivity or allergy to iron supplements,
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the studies,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present studies,
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Human Nutrition Laboratory
Zurich, Canton of Zurich, 8092
About this study
Official title: The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles
Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).
- Conditions
- Iron Deficiency, Anemia, Iron Deficiency Anemia
- Being tested
- Single oral iron dose of 120 mg per day for 3 consecutive days, Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days
- Keywords
- Iron bio-availability, Hepcidin, Iron absorption
- Medical subject headings
- Iron Deficiencies, Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single oral iron dose of 120 mg per day for 3 consecutive daysDietary supplement
Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive daysDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Single oral iron supplement per day (120 mg) | Experimental | Single oral iron dose of 120 mg per day for 3 consecutive days Receives: Dietary Supplement: Single oral iron dose of 120 mg per day for 3 consecutive days |
| B.i.d. oral iron supplement (2x 60 mg) | Active comparator | Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days Receives: Dietary Supplement: Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron bio-availability (%) from oral iron supplementation (3x 120 mg)
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS).
Measured: 3 days
Serum hepcidin concentrations on the 1st day of iron supplementation
Measured: 1 day
Iron bio-availability (%) from oral iron supplementation (6x 60 mg)
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS).
Measured: 6 days
Serum hepcidin concentrations on the 2nd day of iron supplementation
Measured: 2 days
Serum hepcidin concentrations on the 3rd day of iron supplementation
Measured: 3 days
Serum hepcidin concentrations on the 4th day of iron supplementation
Measured: 4 days
Serum hepcidin concentrations on the 5th day of iron supplementation
Measured: 5 days
Serum hepcidin concentrations on the 6th day of iron supplementation
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177851
- Sponsor's protocol ID
- FeSupp_Hep-2
- Status last verified
- Sep 2015
- First submitted
- 25 Jun 2014
- Last updated
- 21 Jan 2016
- Results posted
- No
Publications
Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.
PubMed 29032957
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles
- ClinicalTrials.gov ID
- NCT02177851
- Acronym / sponsor ID
- FeSupp_Hep-2
- Conditions
- Iron Deficiency, Anemia, Iron Deficiency Anemia
- Keywords
- Iron bio-availability, Hepcidin, Iron absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jun 2014 (estimated)
- 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.
Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single oral iron supplement per day (120 mg) | Experimental | Dietary Supplement: Single oral iron dose of 120 mg per day for 3 consecutive daysSingle oral iron dose of 120 mg per day for 3 consecutive days |
| B.i.d. oral iron supplement (2x 60 mg) | Active comparator | Dietary Supplement: Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive daysTwo oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female, 18 to 45 years old,
- Serum Ferritin levels <20 µg/L,
- Normal body Mass Index (18.5-25 kg/m2),
- Body weight <65 kg,
- Signed informed consent
Key exclusion criteria (15 listed)
- Anaemia (Hb < 11.7 g/dL),
- Elevated c-reactive protein or alpha1 glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively,
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
- Continuous/long-term use of medication during the whole studies (except for contraceptives),
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration,
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 |
|---|---|---|
| Single oral iron dose of 120 mg per day for 3 consecutive days | Dietary supplement | Single oral iron supplement per day (120 mg) |
| Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days | Dietary supplement | B.i.d. oral iron supplement (2x 60 mg) |
Primary outcome
Iron bio-availability (%) from oral iron supplementation (3x 120 mg)
Time frame: 3 days
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS).
Serum hepcidin concentrations on the 1st day of iron supplementation
Time frame: 1 day
Iron bio-availability (%) from oral iron supplementation (6x 60 mg)
Time frame: 6 days
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS).
Serum hepcidin concentrations on the 2nd day of iron supplementation
Time frame: 2 days
Serum hepcidin concentrations on the 3rd day of iron supplementation
Time frame: 3 days
Serum hepcidin concentrations on the 4th day of iron supplementation
Time frame: 4 days
Serum hepcidin concentrations on the 5th day of iron supplementation
Time frame: 5 days
Serum hepcidin concentrations on the 6th day of iron supplementation
Time frame: 6 days
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 21 Jan 2016.
- Derived from this study: PubMed 29032957Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single oral iron dose of 120 mg per day for 3 consecutive days and Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days in people with Iron Deficiency and Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 15 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 21 Jan 2016. 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 Switzerland. 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?
Iron bio-availability (%) from oral iron supplementation (3x 120 mg) (time frame: 3 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02177851, which also lists 1 linked publication.
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 21 Jan 2016.