Iron Bioavailability From Fortified Food

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iron Bioavailability From Cubes

NCT02327299

Iron Deficiency

COMPLETED NA

Bioavailability of Iron From Savoury Food Product

NCT02280915

Healthy Iron Deficiency

COMPLETED NA

Iron Bioavailability From Dairy Product

NCT02585661

Healthy Volunteers

COMPLETED NA

Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate

NCT01053442

Iron Deficiency

COMPLETED NA

Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores

NCT03325270

Iron-deficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Bioavailability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Labeled iron salt (Fe54)

Labeled iron salt (Fe54) with bouillon

Group Type ACTIVE_COMPARATOR

Labeled iron salt Fe54

Intervention Type OTHER

Fe salt enriched with Fe 54 isotopes

Labeled iron salt (Fe57)

Labeled iron salt (Fe57) with bouillon

Group Type ACTIVE_COMPARATOR

Labeled iron salt Fe57

Intervention Type OTHER

Fe salt enriched with Fe 57 isotopes

Labeled iron salt (Fe58)

Labeled iron salt (Fe58) with bouillon

Group Type EXPERIMENTAL

Labeled iron salt Fe58

Intervention Type OTHER

Fe salt enriched with Fe 58 isotopes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Labeled iron salt Fe54

Fe salt enriched with Fe 54 isotopes

Intervention Type OTHER

Labeled iron salt Fe57

Fe salt enriched with Fe 57 isotopes

Intervention Type OTHER

Labeled iron salt Fe58

Fe salt enriched with Fe 58 isotopes

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes