Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women
NTBIwomen
The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 27, 2011
CompletedFirst Posted
Study publicly available on registry
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 6, 2016
January 1, 2012
2.1 years
July 27, 2011
January 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Formation of NTBI following oral iron administration
6 time points within 8 hours
Secondary Outcomes (1)
Serum iron isotope appearance curves
6 time points within 8 hours
Study Arms (3)
Iron supplement without food
EXPERIMENTALIron supplement with food
EXPERIMENTALIron fortificant with food
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- non pregnant
- non lactating
- apparently healthy women
You may not qualify if:
- chronic disease
- pregnancy
- lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss Federal Institute of Technologylead
- Columbia Universitycollaborator
Study Sites (1)
ETH Zurich
Zurich, 8092, Switzerland
Related Publications (1)
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.
PMID: 25057155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Hurrell, PhD
ETH Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2011
First Posted
July 28, 2011
Study Start
November 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
January 6, 2016
Record last verified: 2012-01