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Completed

NCT Number: NCT01404533

Iron Interventions and 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non pregnant
  • non lactating
  • apparently healthy women

Exclusion criteria

  • chronic disease
  • pregnancy
  • lactation

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

60 mg Ferrous sulfate

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

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Columbia University

Registry information

Official study title

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

Acronym: NTBIwomen

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2011
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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