Iron DeficiencyNCT02096250
Iron Absorption in Haiti
A study testing NaFeEDTA, Ferrous fumarate and NaFeEDTA + ferrous fumarate in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Haiti.
Trial summary
The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- NaFeEDTA, Ferrous fumarate and NaFeEDTA + ferrous fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteHaiti
- Study dates
- Jun 2014to Jul 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of reproductive age (18 to 45 years)
- Generally healthy
- Consenting to study participation
- Age 4 years +/- 12 months
- Generally healthy
Who cannot join
- Pregnancy or lactation
- Weight >65 kg
- Chronic illnesses which may influence iron absorption
- Severe anemia (Hb<10 g/dl)
- Severe anemia (Hb<10 g/dl)
- Weight for height < -2 Z scores (wasting)
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- Height of age < -2 Z score (stunting)
- Furthermore, the following exclusion criteria apply to both mothers and children :
- Chronic illnesses or medication which may influence iron absorption (will be judged by investigator)
- Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit)
- Allergies or intolerances relevant to the test meal (gluten)
- Blood donation or major blood losses during the 2 months prior to the study
- Illness during the 4 weeks prior to the study (will be judged by investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Absorption From Wheat Flour in Haiti
The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.
- Conditions
- Iron Deficiency
- Being tested
- NaFeEDTA, Ferrous fumarate, NaFeEDTA + ferrous fumarate
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaFeEDTAOther
Ferrous fumarateOther
NaFeEDTA + ferrous fumarateOther
| Study group | Role | What they receive |
|---|---|---|
| NaFeEDTA | Experimental | NaFeEDTA Receives: Other: NaFeEDTA |
| Ferrous fumarate | Experimental | Ferrous fumarate Receives: Other: Ferrous fumarate |
| NaFeEDTA + ferrous fumarate | Experimental | NaFeEDTA + ferrous fumarate Receives: Other: NaFeEDTA + ferrous fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron absorption
Measured: 14 days after test meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionJul 2015
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Principal investigator, Isabelle Aeberli, Swiss Federal Institute of Technology
- Investigators
- Isabelle Aeberli, PhD, Principal investigator, ETH Zurich (Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096250
- Sponsor's protocol ID
- EK 2013-N43
- Status last verified
- Sep 2015
- First submitted
- 21 Mar 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption From Wheat Flour in Haiti
- ClinicalTrials.gov ID
- NCT02096250
- Acronym / sponsor ID
- EK 2013-N43
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Mar 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.
The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NaFeEDTA | Experimental | Other: NaFeEDTANaFeEDTA |
| Ferrous fumarate | Experimental | Other: Ferrous fumarateFerrous fumarate |
| NaFeEDTA + ferrous fumarate | Experimental | Other: NaFeEDTA + ferrous fumarateNaFeEDTA + ferrous fumarate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women of reproductive age (18 to 45 years)
- Generally healthy
- Consenting to study participation
- Age 4 years +/- 12 months
- Generally healthy
Key exclusion criteria (13 listed)
- Pregnancy or lactation
- Weight >65 kg
- Chronic illnesses which may influence iron absorption
- Severe anemia (Hb<10 g/dl)
- Severe anemia (Hb<10 g/dl)
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 |
|---|---|---|
| NaFeEDTA | Other | NaFeEDTA |
| Ferrous fumarate | Other | Ferrous fumarate |
| NaFeEDTA + ferrous fumarate | Other | NaFeEDTA + ferrous fumarate |
Primary outcome
Iron absorption
Time frame: 14 days after test meal consumption
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 23 Sep 2015.
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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.
Isabelle Aeberli, PhD principal investigator
ETH Zurich (Switzerland)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaFeEDTA, Ferrous fumarate and NaFeEDTA + ferrous fumarate in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Haiti.
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 13 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 23 Sep 2015. 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 Haiti. 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: 14 days after test meal consumption). 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 23 Sep 2015.