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

Not Applicable

Completed

• Conditions: Iron Deficiency
• Interventions: Dietary Supplement: Ferrous sulfate

• Registration Number: NCT01404533
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• non pregnant
• non lactating
• apparently healthy women

Exclusion Criteria

• chronic disease
• pregnancy
• lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Iron supplement without food	Ferrous sulfate	-
Iron fortificant with food	Ferrous sulfate	-
Iron supplement with food	Ferrous sulfate	-

Primary Outcome Measures

Name	Time	Method
Formation of NTBI following oral iron administration	6 time points within 8 hours

Secondary Outcome Measures

Name	Time	Method
Serum iron isotope appearance curves	6 time points within 8 hours

Trial Locations

Locations (1)

ETH Zurich; 🇨🇭 Zurich, Switzerland