Iron DeficiencyNCT02175888
The Optimization of Bioavailability From Iron Supplements: Study 1
A study testing Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days and Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 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?
- Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days and Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 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
- Oct 2015to Jan 2016
- 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 </=25 µg/L,
- Normal body Mass Index (18.5-26.5 kg/m2),
- Body weight <80 kg,
- Signed informed consent
Who cannot join
- Anaemia (Hb < 8.0 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.
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 present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily.
The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.
- Conditions
- Iron Deficiency, Anemia, Iron Deficiency Anemia
- Being tested
- Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days, Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 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.
Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive daysDietary supplement
Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 daysDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Oral iron supplement every day for 14 days | Experimental | Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days Receives: Dietary Supplement: Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days |
| Oral iron supplement every second day for 28 days | Active comparator | Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days Receives: Dietary Supplement: Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 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 (%)
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: up to 4 weeks
Serum hepcidin concentrations
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 21, 23, 25 and 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- 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
- Investigators
- Diego Moretti, PhD, Principal investigator, Human Nutrition Laboratory, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175888
- Sponsor's protocol ID
- FeSupp_Hep-1
- Status last verified
- May 2015
- First submitted
- 25 Jun 2014
- Last updated
- 7 Nov 2017
- Results posted
- No
Publications
Lazrak M, El Kari K, Stoffel NU, Elammari L, Al-Jawaldeh A, Loechl CU, Yahyane A, Barkat A, Zimmermann MB, Aguenaou H. Tea Consumption Reduces Iron Bioavailability from NaFeEDTA in Nonanemic Women and Women with Iron Deficiency Anemia: Stable Iron Isotope Studies in Morocco. J Nutr. 2021 Sep 4;151(9):2714-2720. doi: 10.1093/jn/nxab159.
PubMed 34038558Stoffel 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 7 Nov 2017. 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
- NCT02175888
- Acronym / sponsor ID
- FeSupp_Hep-1
- 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
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 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 present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily.
The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral iron supplement every day for 14 days | Experimental | Dietary Supplement: Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive daysDaily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days |
| Oral iron supplement every second day for 28 days | Active comparator | Dietary Supplement: Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 daysAdministrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 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 </=25 µg/L,
- Normal body Mass Index (18.5-26.5 kg/m2),
- Body weight <80 kg,
- Signed informed consent
Key exclusion criteria (15 listed)
- Anaemia (Hb < 8.0 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 |
|---|---|---|
| Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days | Dietary supplement | Oral iron supplement every day for 14 days |
| Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days | Dietary supplement | Oral iron supplement every second day for 28 days |
Primary outcome
Iron bio-availability from oral iron supplementation (%)
Time frame: up to 4 weeks
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
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 21, 23, 25 and 27 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 7 Nov 2017.
- Derived from this study: PubMed 34038558Lazrak M, El Kari K, Stoffel NU, Elammari L, Al-Jawaldeh A, Loechl CU, Yahyane A, Barkat A, Zimmermann MB, Aguenaou H. Tea Consumption Reduces Iron Bioavailability from NaFeEDTA in Nonanemic Women and Women with Iron Deficiency Anemia: Stable Iron Isotope Studies in Morocco. J Nutr. 2021 Sep 4;151(9):2714-2720. doi: 10.1093/jn/nxab159.
- 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.
Diego Moretti, PhD principal investigator
Human Nutrition Laboratory, ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days and Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 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 7 Nov 2017. 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 (%) (time frame: up to 4 weeks). The study lists 2 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 NCT02175888, which also lists 2 linked publications.
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 7 Nov 2017.