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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02280915
Other study ID # FDS-SAV-1615
Secondary ID
Status Completed
Phase N/A
First received October 21, 2014
Last updated April 30, 2015
Start date October 2014
Est. completion date March 2015

Study information

Verified date April 2015
Source Unilever R&D
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy female subjects;

- 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 iron deficiency (Serum ferritin <15µg/L);

- 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.

Exclusion Criteria:

- 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;

- 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;

- Participation in another clinical trial during the last 30 days prior to the beginning of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Savoury food product


Locations

Country Name City State
Switzerland Laboratory of human nutrition - ETH Zurich

Sponsors (1)

Lead Sponsor Collaborator
Unilever R&D

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products Amounts of Fe isotopic label present in the blood 14 days after administration of the fortified savoury food product will be calculated based on measured shifts in the iron isotope ratios in the blood samples (Day 15) compared to baseline and the amount of iron circulating in the body 15 days No
Secondary To assess the relative bioavailability of iron from iron fortified savoury food products The absolute bioavailability results of each of the iron fortified savoury products as obtained under the primary objective will be compared with each other 15 days No
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