Iron Bioavailability From Cubes

NCT02327299 | Completed DMC

• 1 other identifier: FDS-SAV-1615
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Iron Deficiency

Keywords

Iron deficiency; Iron fortification

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

FePP

EXPERIMENTAL

Bouillon fortified with 4mg FePP

Dietary Supplement: Bouillon fortified with FePP

FePP + Stabilizer

EXPERIMENTAL

Bouillon fortified with 4mg FePP + Stabilizer

Dietary Supplement: Bouillon fortified with FePP + Stabilizer

FeSO4

EXPERIMENTAL

Bouillon fortified with 4mg FeSO4

Dietary Supplement: Bouillon fortified with FeSO4

FeSO4 + Stabilizer

EXPERIMENTAL

Bouillon fortified with 4mg FeSO4 + Stabilizer

Dietary Supplement: Bouillon fortified with FeSO4 + Stabilizer

Interventions

Bouillon fortified with FePP DIETARY_SUPPLEMENT

FePP

Bouillon fortified with FePP + Stabilizer DIETARY_SUPPLEMENT

FePP + Stabilizer

Bouillon fortified with FeSO4 DIETARY_SUPPLEMENT

FeSO4

Bouillon fortified with FeSO4 + Stabilizer DIETARY_SUPPLEMENT

FeSO4 + Stabilizer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12