Iron DeficiencyNCT01687062
Iron Absorption From Tef-injera in Women of Reproductive Age
A study testing FeSO4, reduction of phytate and NaFeEDTA in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Anemia is one of the most common health problems all over the world with around half of preschool-aged children (<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- FeSO4, reduction of phytate and NaFeEDTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Oct 2013
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reproductive age females 18-40 years
- Maximum body weight 65 kg
- Normal body mass index (18.5-25 kg/m2)
- No intake of mineral/vitamin supplements 2 weeks before and during the study
- No metabolic or gastrointestinal disorders or chronic diseases
- Not pregnant or lactating
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- No regular intake of medication (except oral contraceptives)
- No blood donation or significant blood loss (accident, surgery) over the past 4 months
- Not currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- No former participation in a study involving administration of iron stable isotopes
- No eating disorders or food allergy
- Subject who can be expected and are willing to comply with study protocol
- Having received oral and written information about the aims and procedures of the study
- Having provided oral and written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Anemia is one of the most common health problems all over the world with around half of preschool-aged children (<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. So in Ethiopia, where injera is the major staple food. Despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.
The aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be evaluated. Further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. The phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. The studies will be conducted in healthy women using stable isotope techniques.
- Conditions
- Iron Deficiency
- Being tested
- FeSO4, reduction of phytate, NaFeEDTA
- Keywords
- NaFeEDTA, phytate, injera, iron absorption
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeSO4Other
reduction of phytateOther
NaFeEDTAOther
| Study group | Role | What they receive |
|---|---|---|
| FeSO4 + high phytate | Active comparator | injera test meal 1 labeled with a 4 mg staple iron isotope tag Receives: Other: FeSO4 |
| FeSO4 + medium phytate | Experimental | injera test meal 2 labeled with a 4 mg staple iron isotope tag Receives: Other: FeSO4; Other: reduction of phytate |
| FeSO4 + low phytate | Experimental | injera test meal 3 labeled with a 4 mg staple iron isotope tag Receives: Other: FeSO4; Other: reduction of phytate |
| FeSO4 + NaFeEDTA (1:1) + high phytate | Experimental | injera test meal 4 labeled with a 4 mg staple iron isotope tag Receives: Other: FeSO4; Other: NaFeEDTA |
| FeSO4 + NaFeEDTA (1:3) + high phytate | Experimental | injera test meal 5 labeled with a 4 mg staple iron isotope tag Receives: Other: FeSO4; Other: NaFeEDTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron absorption
Test meals with isotopic iron labels will be administrated on day 1-3. Whole blood samples will be collected on day 17 (14 after the last test meal) to analyze the iron isotope ratios.
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687062
- Sponsor's protocol ID
- EK2012N31
- Status last verified
- Oct 2013
- First submitted
- 13 Sep 2012
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption From Tef-injera in Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT01687062
- Acronym / sponsor ID
- EK2012N31
- Conditions
- Iron Deficiency
- Keywords
- NaFeEDTA, phytate, injera, iron absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Sep 2012 (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.
Anemia is one of the most common health problems all over the world with around half of preschool-aged children (<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. So in Ethiopia, where injera is the major staple food. Despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.
The aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be evaluated. Further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. The phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. The studies will be conducted in healthy women using stable isotope techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FeSO4 + high phytate | Active comparator | Other: FeSO4injera test meal 1 labeled with a 4 mg staple iron isotope tag |
| FeSO4 + medium phytate | Experimental | Other: FeSO4, Other: reduction of phytateinjera test meal 2 labeled with a 4 mg staple iron isotope tag |
| FeSO4 + low phytate | Experimental | Other: FeSO4, Other: reduction of phytateinjera test meal 3 labeled with a 4 mg staple iron isotope tag |
| FeSO4 + NaFeEDTA (1:1) + high phytate | Experimental | Other: FeSO4, Other: NaFeEDTAinjera test meal 4 labeled with a 4 mg staple iron isotope tag |
| FeSO4 + NaFeEDTA (1:3) + high phytate | Experimental | Other: FeSO4, Other: NaFeEDTAinjera test meal 5 labeled with a 4 mg staple iron isotope tag |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Reproductive age females 18-40 years
- Maximum body weight 65 kg
- Normal body mass index (18.5-25 kg/m2)
- No intake of mineral/vitamin supplements 2 weeks before and during the study
- No metabolic or gastrointestinal disorders or chronic diseases
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FeSO4 | Other | FeSO4 + NaFeEDTA (1:1) + high phytate, FeSO4 + NaFeEDTA (1:3) + high phytate, FeSO4 + high phytate, FeSO4 + low phytate, FeSO4 + medium phytate |
| reduction of phytate | Other | FeSO4 + low phytate, FeSO4 + medium phytate |
| NaFeEDTA | Other | FeSO4 + NaFeEDTA (1:1) + high phytate, FeSO4 + NaFeEDTA (1:3) + high phytate |
Primary outcome
Iron absorption
Time frame: 17 days
Test meals with isotopic iron labels will be administrated on day 1-3. Whole blood samples will be collected on day 17 (14 after the last test meal) to analyze the iron isotope ratios.
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 14 Oct 2013.
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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 FeSO4, reduction of phytate and NaFeEDTA in people with Iron Deficiency, 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 14 inclusion and 0 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 14 Oct 2013. 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 absorption (time frame: 17 days). 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 14 Oct 2013; AzTrials last refreshed its copy on 8 Nov 2026.