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OpenTrials
Completed

NCT Number: NCT02255942

The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate

Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zürich, Laboratory of Human Nutrition

Zurich, Canton of Zurich, 8092, Switzerland

About this study

Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to fortify rice and other foods as it causes no organoleptic changes to the food vehicles. However, it is only of low absorption in man and its absorption can be influenced by a variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on iron bioavailability in extruded rice fortified with FePP has never been investigated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Serum Ferritin Level < 15 µg/L
  • Body weight <65 kg
  • Signed informed consent 4. Body Mass Index in the range of 18.5 to 25

Exclusion criteria

-

Treatment and study plan

Ferric Pyrophosphate and Zinc Oxide

Other

Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)

Ferrous sulfate

Other

Rice fortified with Ferrous Sulfate (ZnSO4)

Ferric Pyrophosphate and Zinc Sulfate

Other

Rice fortified with Ferric Pyrophosphate and Zinc Sulfate

Ferric Pyrophosphate

Other

Rice fortified with Ferric Pyrophosphate

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Haemoglobin

    Time frame: baseline, 16th, 30th and 44th day

    14 or 15 days after each meal administration and at baseline

  2. Plasma Ferritin

    Time frame: baseline, 16th, 30th and 44th day

    14 or 15 days after each meal administration and at baseline

  3. C reactive protein

    Time frame: baseline, 16th, 30th and 44th day

    14 or 15 days after each meal administration and at baseline

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • PATH

Registry information

Acronym: Rice_FeZn

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2014
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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