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

The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01404533
Acronym
NTBIwomen
Enrollment
32
Registered
2011-07-28
Start date
2009-11-30
Completion date
2011-12-31
Last updated
2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Keywords

NTBI, Iron, Absorption

Brief 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.

Interventions

DIETARY_SUPPLEMENTFerrous sulfate

60 mg Ferrous sulfate

Sponsors

Columbia University
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* non pregnant * non lactating * apparently healthy women

Exclusion criteria

* chronic disease * pregnancy * lactation

Design outcomes

Primary

MeasureTime frame
Formation of NTBI following oral iron administration6 time points within 8 hours

Secondary

MeasureTime frame
Serum iron isotope appearance curves6 time points within 8 hours

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026