Iron Bioavailability From Fortified Food

NCT02993835 | Completed

• 1 other identifier: 16.15.NRC
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Determination of fractional iron absorption from bouillon fortified with 3 labeled iron compounds.

Conditions

Iron Bioavailability

Outcome Measures

Primary Outcomes (1)

• Relative iron bioavailability (RBV) of 58Fe salt to 54Fe salt (i.e. FIA of 58Fe salt divided by FIA of 54Fe salt), RBV of 57Fe salt to 54Fe salt and RBV of 58Fe salt to 57Fe salt. The determination of FIA is a prerequisite for this calculation.

  FIA will be calculated based on the measured shift of iron isotope ratios in the blood 14 days after the test meal administrations. The amounts of 57Fe, 54Fe and 58Fe in the blood will be calculated on the principle of isotope dilution by considering that iron isotopic labels are not mono-isotopic (Walczyk et al., 1997; Cercamondi, 2013). Circulating iron will be calculated based on blood volume and hemoglobin concentration (Kastenmayer et al., 1994). Blood volume will be indirectly measured based on height and weight and calculated using the formula proposed by Brown et al (1962). For calculations of fractional absorption, 80% incorporation of the absorbed iron into red blood cells is assumed.

  14 days after last stable isotope adminstration

Study Arms (3)

Labeled iron salt (Fe54)

ACTIVE COMPARATOR

Labeled iron salt (Fe54) with bouillon

Other: Labeled iron salt Fe54

Labeled iron salt (Fe57)

ACTIVE COMPARATOR

Labeled iron salt (Fe57) with bouillon

Other: Labeled iron salt Fe57

Labeled iron salt (Fe58)

EXPERIMENTAL

Labeled iron salt (Fe58) with bouillon

Other: Labeled iron salt Fe58

Interventions

Labeled iron salt Fe54 OTHER

Fe salt enriched with Fe 54 isotopes

Labeled iron salt (Fe54)

Labeled iron salt Fe57 OTHER

Fe salt enriched with Fe 57 isotopes

Labeled iron salt (Fe57)

Labeled iron salt Fe58 OTHER

Fe salt enriched with Fe 58 isotopes

Labeled iron salt (Fe58)

Eligibility Criteria

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

You may qualify if:

• Women aged 18-40 years old
• Healthy, based on the medical screening visit including a blood formula
• Normal BMI for age (18.5-25.0 kg/m2)
• Weight less than 65 kg
• Able to understand and to sign written informed consent prior to trial entry
• Informed consent signed

You may not qualify if:

• Anemia or polycythemia respectively evidenced by one of the following criteria from a standard blood formula: number of erythrocytes 4.0 - 5.8 1012/l or Hb 120-160 g/l or Ht 35-55%. Subjects outside of this range will be excluded.
• Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation and other causes to be appreciated by the investigator).
• Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.
• Any therapy or medication taken for any infectious and inflammatory disease in the past two weeks.
• Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
• Diagnosed food allergy.
• Pregnancy (tested in plasma at screening) and/or lactation.
• History of cancer within the past year.
• Significant weight loss during the last 3 months (10% and more)
• Any medication or supplement which may impact erythrocytes, Hb or Ht (to the opinion of the investigator).
• Iron supplementation therapy or perfusion in the last three months.
• Smokers (\> 5 cigarettes per day).
• Have a high alcohol consumption (more than 2 drinks/day).
• Consumption of illicit drugs (anamnesis only).
• Subject having a hierarchical link with the investigator or co-investigators.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

ETH Zurich, Human Nutrition Laboratory

Zurich, 8092, Switzerland

Location

Study Officials

• Diego Moretti, PhD

  ETH Zurich, Human Nutrition Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)