Iron Bioavailability From Fortified Food

Iron Bioavailability From Fortified Food in Healthy Women

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

Study Overview

• Status: Completed
• Conditions: Iron Bioavailability
• Intervention / Treatment: Other: Labeled iron salt Fe54; Other: Labeled iron salt Fe57; Other: Labeled iron salt Fe58

Detailed Description

This single center trial will be single-blind to the subject, controlled, fully randomized with crossover design in 22 healthy females aged 18-40 years old.

Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after last stable isotope intake blood sampling (V7).

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8092
    • ETH Zurich, Human Nutrition Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation and other causes to be appreciated by the investigator).
3. Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.
4. Any therapy or medication taken for any infectious and inflammatory disease in the past two weeks.
5. Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
6. Diagnosed food allergy.
7. Pregnancy (tested in plasma at screening) and/or lactation.
8. History of cancer within the past year.
9. Significant weight loss during the last 3 months (10% and more)
10. Any medication or supplement which may impact erythrocytes, Hb or Ht (to the opinion of the investigator).
11. Iron supplementation therapy or perfusion in the last three months.
12. Smokers (> 5 cigarettes per day).
13. Have a high alcohol consumption (more than 2 drinks/day).
14. Consumption of illicit drugs (anamnesis only).
15. Subject having a hierarchical link with the investigator or co-investigators.
16. Subject who cannot be expected to comply with treatment or study procedure.
17. Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
18. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Labeled iron salt (Fe54); Labeled iron salt (Fe54) with bouillon	Other: Labeled iron salt Fe54; Fe salt enriched with Fe 54 isotopes
Active Comparator: Labeled iron salt (Fe57); Labeled iron salt (Fe57) with bouillon	Other: Labeled iron salt Fe57; Fe salt enriched with Fe 57 isotopes
Experimental: Labeled iron salt (Fe58); Labeled iron salt (Fe58) with bouillon	Other: Labeled iron salt Fe58; Fe salt enriched with Fe 58 isotopes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Diego Moretti, PhD, ETH Zurich, Human Nutrition Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 16.15.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO