Iron DeficiencyNTBIwomenNCT01404533
Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women
A study testing Ferrous sulfate in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). 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
- What is being tested?
- Ferrous sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2009to Dec 2011
- 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
- non pregnant
- non lactating
- apparently healthy women
Who cannot join
- chronic disease
- pregnancy
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women
The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (~0.1 mg Fe/kg) - like that used in home fortification - with the standard rice meal.
- Conditions
- Iron Deficiency
- Being tested
- Ferrous sulfate
- Keywords
- NTBI, 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.
Ferrous sulfateDietary supplement
60 mg Ferrous sulfate
Ferrous sulfateDietary supplement
60 mg ferrous sulfate
Ferrous sulfateDietary supplement
6 mg ferrous sulfate
| Study group | Role | What they receive |
|---|---|---|
| Iron supplement without food | Experimental | Not described Receives: Dietary Supplement: Ferrous sulfate |
| Iron supplement with food | Experimental | Not described Receives: Dietary Supplement: Ferrous sulfate |
| Iron fortificant with food | Experimental | Not described Receives: Dietary Supplement: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formation of NTBI following oral iron administration
Measured: 6 time points within 8 hours
Secondary outcomes (1)
Serum iron isotope appearance curves
Measured: 6 time points within 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completionDec 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Richard Hurrell, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404533
- Sponsor's protocol ID
- NTBI women
- Acronym
- NTBIwomen
- Status last verified
- Jan 2012
- First submitted
- 27 Jul 2011
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Brittenham GM, Andersson M, Egli I, Foman JT, Zeder C, Westerman ME, Hurrell RF. Circulating non-transferrin-bound iron after oral administration of supplemental and fortification doses of iron to healthy women: a randomized study. Am J Clin Nutr. 2014 Sep;100(3):813-20. doi: 10.3945/ajcn.113.081505. Epub 2014 Jul 23.
PubMed 25057155
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women
- ClinicalTrials.gov ID
- NCT01404533
- Acronym / sponsor ID
- NTBIwomen / NTBI women
- Conditions
- Iron Deficiency
- Keywords
- NTBI, Iron, Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jul 2011 (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 overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (~0.1 mg Fe/kg) - like that used in home fortification - with the standard rice meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron supplement without food | Experimental | Dietary Supplement: Ferrous sulfate |
| Iron supplement with food | Experimental | Dietary Supplement: Ferrous sulfate |
| Iron fortificant with food | Experimental | Dietary Supplement: Ferrous sulfate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non pregnant
- non lactating
- apparently healthy women
Key exclusion criteria (3 listed)
- chronic disease
- pregnancy
- lactation
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 |
|---|---|---|
| Ferrous sulfate60 mg Ferrous sulfate | Dietary supplement | Iron supplement without food |
| Ferrous sulfate60 mg ferrous sulfate | Dietary supplement | Iron supplement with food |
| Ferrous sulfate6 mg ferrous sulfate | Dietary supplement | Iron fortificant with food |
Primary outcome
Formation of NTBI following oral iron administration
Time frame: 6 time points within 8 hours
1 secondary outcome
Serum iron isotope appearance curves
Time frame: 6 time points within 8 hours
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 6 Jan 2016.
- Derived from this study: PubMed 25057155Brittenham GM, Andersson M, Egli I, Foman JT, Zeder C, Westerman ME, Hurrell RF. Circulating non-transferrin-bound iron after oral administration of supplemental and fortification doses of iron to healthy women: a randomized study. Am J Clin Nutr. 2014 Sep;100(3):813-20. doi: 10.3945/ajcn.113.081505. Epub 2014 Jul 23.
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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.
Richard Hurrell, PhD principal investigator
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 Ferrous sulfate 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 3 inclusion and 3 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 6 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?
Formation of NTBI following oral iron administration (time frame: 6 time points within 8 hours). 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 NCT01404533, 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 6 Jan 2016.