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

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Iron Deficiency

Treatments

Dietary Supplement: Ferrous sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT01404533
NTBI women

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • non pregnant
  • non lactating
  • apparently healthy women

Exclusion criteria

  • chronic disease
  • pregnancy
  • lactation

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 3 patient groups

Iron supplement without food
Experimental group
Treatment:
Dietary Supplement: Ferrous sulfate
Dietary Supplement: Ferrous sulfate
Dietary Supplement: Ferrous sulfate
Iron supplement with food
Experimental group
Treatment:
Dietary Supplement: Ferrous sulfate
Dietary Supplement: Ferrous sulfate
Dietary Supplement: Ferrous sulfate
Iron fortificant with food
Experimental group
Treatment:
Dietary Supplement: Ferrous sulfate
Dietary Supplement: Ferrous sulfate
Dietary Supplement: Ferrous sulfate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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