Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women (NTBIwomen)
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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 |
- Formation of NTBI following oral iron administration [ Time Frame: 6 time points within 8 hours ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- non pregnant
- non lactating
- apparently healthy women
Exclusion Criteria:
- chronic disease
- pregnancy
- lactation
Contacts and Locations
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 May 23, 2013