Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Zinc, Citric Acid/Trisodium Citrate and EDTA

Summary

Rice can only be fortified with ferric pyrophosphate (FePP), which is of low bioavailability in human subjects. Compounds such as citric acid/trisodium citrate (CA/TSC) or sodium ethylene-diamine tetraacetic-acid (EDTA) could serve as absorption enhancers. Recent findings from single meal studies indicate CA/TSC to have an enhancing effect on iron absorption from FePP-fortified rice. In contrast, ZnO has been suggested to have detrimental effects. Furthermore, in vitro findings suggest an increased iron solubility from iron and EDTA-co-fortified rice - but the bioavailability in humans remains to be investigated. These effects should thus be investigated in 'real-life' conditions, when fortified rice is implemented in a complete diet administered throughout several days in a target population for a rice fortification program.

Objective: To assess iron absorption from the diet from different iron fortified rice formulations in iron deficient anaemic children.

The investigators aim to conduct an iron absorption study in 30 Ghanaian school-age children investigating different fortification approaches in a multiple meal randomized, cross over study.

Conditions

• Iron Deficiency and/or Anemia

Interventions

OTHER

Ferric Pyrophosphate and Zinc Oxide

Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO) and micronutrients

OTHER

Ferric Pyrophosphate and Zinc Sulphate

Extruded rice fortified with Ferric Pyrophosphate, Zinc Sulphate (ZnSO4) and micronutrients

OTHER

Ferric Pyrophosphate, ZnO, Citric Acid and Trisodium Citrate

Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO), Citric Acid (CA) and Trisodium Citrate (TSC) and micronutrients

OTHER

Ferric Pyrophosphate, ZnSO4, CA/TSC

Extruded rice fortified with Ferric Pyrophosphate, ZnSO4, CA/TSC and micronutrients

OTHER

Ferric Pyrophosphate, ZnO, CA, EDTA

Extruded rice fortified with Ferric Pyrophosphate, ZnO, CA, EDTA and micronutrients

OTHER

Ferrous Sulphate

Extruded rice fortified with micronutrients, Ferrous Sulphate solution will be added at consumption

Sponsors & Collaborators

• University for Development Studies, Tamale, Ghana

  collaborator OTHER

• Swiss Federal Institute of Technology

  lead OTHER

Principal Investigators

• Michael B Zimmermann, Prof. Dr. · Swiss FIT

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• Ghana
• Switzerland

Study Locations