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

Iron Deficiency Clinical Trial

— NTBIwomen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404533
• Other study ID #: NTBI women
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: January 5, 2016
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: ETH Ethical committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• non pregnant

• non lactating

• apparently healthy women

Exclusion Criteria:

• chronic disease

• pregnancy

• lactation

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• Ferrous sulfate
60 mg Ferrous sulfate
• Ferrous sulfate
60 mg ferrous sulfate
• Ferrous sulfate
6 mg ferrous sulfate

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Columbia University

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formation of NTBI following oral iron administration		6 time points within 8 hours	No
Secondary	Serum iron isotope appearance curves		6 time points within 8 hours	No