CClinicalTrials.gg
CompletedNCT01404533NTBIwomenUpdated Jan 6, 2016

Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women

An interventional study of Ferrous sulfate and Ferrous sulfate in Iron Deficiency, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-06.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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). 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.

02

Conditions studied

  • Iron Deficiency

Browse trials for

Keywords

  • NTBI
  • Iron
  • Absorption
03

In context

Iron Deficiencies

772 studies on the registry are indexed under Iron Deficiencies; 115 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 592 interventional studies indexed under Iron Deficiencies.

Browse Iron Deficiencies studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • non pregnant
  • non lactating
  • apparently healthy women

Exclusion criteria

Exclusion Criteria:

  • chronic disease
  • pregnancy
  • lactation
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Iron supplement without food

    Dietary Supplement: Ferrous sulfate

  • Experimental
    Iron supplement with food

    Dietary Supplement: Ferrous sulfate

  • Experimental
    Iron fortificant with food

    Dietary Supplement: Ferrous sulfate

Interventions

  • Dietary supplementFerrous sulfate

    60 mg Ferrous sulfate

  • Dietary supplementFerrous sulfate

    60 mg ferrous sulfate

  • Dietary supplementFerrous sulfate

    6 mg ferrous sulfate

06

What researchers measure

Primary outcomes

  1. Formation of NTBI following oral iron administration

    Time frame: 6 time points within 8 hours

Secondary outcomes

  1. Serum iron isotope appearance curves

    Time frame: 6 time points within 8 hours

07

Study locations

1 site
  • ETH Zurich
    Zurich, 8092, Switzerland
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01404533
Lead sponsor
Swiss Federal Institute of Technology
Collaborators
Columbia University
Responsible party
Sponsor
First posted
Jul 28, 2011
Start date
Nov 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jan 6, 2016

Study contacts

Richard Hurrell, PhD
principal investigator · ETH Zurich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion