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

This study has been completed.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
ETH Zurich, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01404533
First received: July 27, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Iron Deficiency
Dietary Supplement: Ferrous sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Formation of NTBI following oral iron administration [ Time Frame: 6 time points within 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum iron isotope appearance curves [ Time Frame: 6 time points within 8 hours ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron supplement without food Dietary Supplement: Ferrous sulfate
60 mg Ferrous sulfate
Experimental: Iron supplement with food Dietary Supplement: Ferrous sulfate
60 mg ferrous sulfate
Experimental: Iron fortificant with food Dietary Supplement: Ferrous sulfate
6 mg ferrous sulfate

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non pregnant
  • non lactating
  • apparently healthy women

Exclusion Criteria:

  • chronic disease
  • pregnancy
  • lactation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01404533

Locations
Switzerland
ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
Columbia University
Investigators
Principal Investigator: Richard Hurrell, PhD ETH Zurich
  More Information

No publications provided

Responsible Party: ETH Zurich, Principal investigator, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01404533     History of Changes
Other Study ID Numbers: NTBI women
Study First Received: July 27, 2011
Last Updated: January 4, 2012
Health Authority: Switzerland: ETH Ethical committee

Keywords provided by Swiss Federal Institute of Technology:
NTBI
Iron
Absorption

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014