Iron Bioavailability From Cubes

Iron Deficiency Clinical Trial

— Fe Bouillon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327299
• Other study ID #: FDS-SAV-1615
• Status: Completed
• Phase: N/A
• First received: December 23, 2014
• Last updated: December 23, 2014
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• Bouillon fortified with FePP

• Bouillon fortified with FePP + Stabilizer

• Bouillon fortified with FeSO4

• Bouillon fortified with FeSO4 + Stabilizer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 2 weeks	No
Primary	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.	4 weeks, 6 weeks	No