Clinical trial NCT02993835: Iron Bioavailability From Fortified Food
Official title: Iron Bioavailability From Fortified Food in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Bioavailability
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 14 days after last stable isotope adminstration
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich, Human Nutrition Laboratory
Study officials:
affiliation: ETH Zurich, Human Nutrition Laboratory
name: Diego Moretti, PhD
role: PRINCIPAL_INVESTIGATOR
References: