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Completed

NCT Number: NCT02327299

Iron Bioavailability From Cubes

Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem, especially in developing countries. There are several strategies to correct iron deficiency in populations: besides supplementation with tablets, one of the most sustainable and effective strategies on medium term has been iron fortification, the addition of iron to regularly consumed foods. In fortification, the chemical nature of the compound to be added plays an important role: depending on the compound sensory qualities of the fortified foods can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to bouillon, as was recently suggested by in vitro experiments in the laboratory.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18 and < 40 years at screening;
  • Body weight <65 kg;
  • Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
  • With low iron stores (serum ferritin <15µg/L);
  • Reported intense sporting activities ≤10h/w;
  • Reported alcohol consumption ≤14 units/w;
  • Currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself;
  • Willing and able to participate in the study;
  • Having given a written informed consent.

Exclusion criteria

  • Being an employee of Unilever or the Laboratory of Human Nutrition of the ETH Zürich;
  • Blood donation or significant blood loss over the past 6 months;
  • Reported use of any medically- or self-prescribed diet;
  • Use of medication (except oral contraceptives)
  • Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
  • Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
  • Is pregnant or will be planning pregnancy during the study period;
  • Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
  • Known gastrointestinal or metabolic disorders;
  • Moderate or severe anemia defined as Hb < 90 g/L.
  • Participation in another clinical trial during the last 30 days prior to the beginning of the study.

Treatment and study plan

Bouillon fortified with FePP

Dietary Supplement

Bouillon fortified with FePP + Stabilizer

Dietary Supplement

Bouillon fortified with FeSO4

Dietary Supplement

Bouillon fortified with FeSO4 + Stabilizer

Dietary Supplement

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 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.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Women

Acronym: Fe Bouillon

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 30, 2014
Registry last updated
Dec 30, 2014

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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