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CompletedNCT02327299Fe BouillonUpdated Dec 30, 2014

Iron Bioavailability From Cubes

An interventional study of Bouillon fortified with FePP and Bouillon fortified with FePP + Stabilizer in Iron Deficiency, sponsored by Swiss Federal Institute of Technology. Completed. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-30.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Iron Deficiency

Keywords

  • Iron deficiency
  • Iron fortification
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    FePP

    Bouillon fortified with 4mg FePP

    Dietary Supplement: Bouillon fortified with FePP

  • Experimental
    FePP + Stabilizer

    Bouillon fortified with 4mg FePP + Stabilizer

    Dietary Supplement: Bouillon fortified with FePP + Stabilizer

  • Experimental
    FeSO4

    Bouillon fortified with 4mg FeSO4

    Dietary Supplement: Bouillon fortified with FeSO4

  • Experimental
    FeSO4 + Stabilizer

    Bouillon fortified with 4mg FeSO4 + Stabilizer

    Dietary Supplement: Bouillon fortified with FeSO4 + Stabilizer

Interventions

  • Dietary supplementBouillon fortified with FePP
  • Dietary supplementBouillon fortified with FePP + Stabilizer
  • Dietary supplementBouillon fortified with FeSO4
  • Dietary supplementBouillon fortified with FeSO4 + Stabilizer
06

What researchers measure

Primary outcomes

  1. Change from baseline in the isotopic ratio of iron in blood at week 2

    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

    Time frame: baseline, 2 weeks

  2. Change from week 4 in the isotopic ratio of iron in blood at week 6

    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

    Time frame: 4 weeks, 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02327299
Lead sponsor
Swiss Federal Institute of Technology
Responsible party
Sponsor
First posted
Dec 30, 2014
Start date
Oct 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 30, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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