NCT03703739

Effect of Solubilizing Agents on Iron Absorption From Iron Fortified Rice in Young Women

Status unknown NA Last updated 11 October 2018

What this trial tests

NA trial testing Reference meal 1 in Iron-deficiency in 22 participants. Status unknown.

Timeline

2 October 2018

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	Swiss Federal Institute of Technology
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	22
Start date	2 October 2018
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across Switzerland

Drugs / interventions tested

• Reference meal 1
• Reference 2
• Test meal A
• Test meal B
• Test meal C
• Test meal D
• Test meal E

Conditions studied

• Iron-deficiency — all drugs for Iron-deficiency →

Sponsor

Swiss Federal Institute of Technology

Who can join

Adults 18 to 40, female only, with Iron-deficiency. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in the isotopic ratio of iron in blood at week 2
  Time frame: baseline, 2 weeks
  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
• Change from week 2 in the isotopic ratio of iron in blood at week 4
  Time frame: 2 weeks, 4 weeks
  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
• Change from week 4 in the isotopic ratio of iron in blood at week 6
  Time frame: 4 weeks, 6 weeks
  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
• Change from week 6 in the isotopic ratio of iron in blood at week 8
  Time frame: 6 weeks, 8 weeks
  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
• Change from week 8 in the isotopic ratio of iron in blood at week 10
  Time frame: 8 weeks, 10 weeks
  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Sponsor's own description

Food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. Rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. Therefore, rice may be a promising fortification vehicle. Ferric pyrophosphate (FePP) is an acceptable iron compound for rice fortification, due to its white colour and low reactivity with the rice matrix. However, iron from FePP generally has a low bioavailability. To increase the low iron bioavailability of FePP in fortified rice, ligands acting as solubilizing agents have been suggested, such as citric acid/trisodium citrate (CA/TSC), ethylenediaminetetraacetic acid (EDTA) and sodium pyrophosphate (NaPP).

It is however unclear to which extent CA/TSC would enhance iron bioavailability in presence of phytic acid, a common inhibitor of iron absorption found in whole grains and legumes. Zinc oxide reduces iron bioavailability from FePP with and without CA/TSC, in contrast to Zinc sulphate. It is however unclear if this decrease would be also expected in presence of EDTA as solubilizing agent. Further, NaPP has been suggested as a solubilizing agent, enhancing the bioavailability from FePP in bouillon cubes. This study aim to test its effect in rice. Meals containing a high (bean sauce) and low (mixed vegetable) phytic acid level sauce will be used to simulated varying dietary backgrounds, allowing to answer the question which solubilizing agent is viable in enhancing iron bioavailability.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ferric Pyrophosphate Forms Soluble Iron Coordination Complexes with Zinc Compounds and Solubilizing Agents in Extruded Rice and Predicts Increased Iron Solubility and Bioavailability in Young Women.
   Scheuchzer P, Syryamina VN, Zimmermann MB, Zeder C, et al · · 2023 · cited 2× · PMID 36931746 · DOI 10.1016/j.tjnut.2022.12.003