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

January 5, 2016 updated by: Swiss Federal Institute of Technology

The Influence of Iron Interventions on Formation of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • non pregnant
  • non lactating
  • apparently healthy women

Exclusion Criteria:

  • chronic disease
  • pregnancy
  • lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron supplement without food
Dietary supplement: Ferrous sulfate
60 mg Ferrous sulfate
Dietary supplement: Ferrous sulfate
60 mg ferrous sulfate
Dietary supplement: Ferrous sulfate
6 mg ferrous sulfate
Experimental: Iron supplement with food
Dietary supplement: Ferrous sulfate
60 mg Ferrous sulfate
Dietary supplement: Ferrous sulfate
60 mg ferrous sulfate
Dietary supplement: Ferrous sulfate
6 mg ferrous sulfate
Experimental: Iron fortificant with food
Dietary supplement: Ferrous sulfate
60 mg Ferrous sulfate
Dietary supplement: Ferrous sulfate
60 mg ferrous sulfate
Dietary supplement: Ferrous sulfate
6 mg ferrous sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Formation of NTBI following oral iron administration
Time Frame: 6 time points within 8 hours
6 time points within 8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum iron isotope appearance curves
Time Frame: 6 time points within 8 hours
6 time points within 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

Columbia University

Investigators

  • Principal Investigator: Richard Hurrell, PhD, ETH Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTBI women

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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