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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01687062
Other study ID # EK2012N31
Secondary ID
Status Completed
Phase N/A
First received September 13, 2012
Last updated October 11, 2013
Start date September 2012
Est. completion date October 2013

Study information

Verified date October 2013
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

Anemia is one of the most common health problems all over the world with around half of preschool-aged children (<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. So in Ethiopia, where injera is the major staple food. Despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.

The aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be evaluated. Further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. The phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. The studies will be conducted in healthy women using stable isotope techniques.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2013
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Reproductive age females 18-40 years

- Maximum body weight 65 kg

- Normal body mass index (18.5-25 kg/m2)

- No intake of mineral/vitamin supplements 2 weeks before and during the study

- No metabolic or gastrointestinal disorders or chronic diseases

- Not pregnant or lactating

- No regular intake of medication (except oral contraceptives)

- No blood donation or significant blood loss (accident, surgery) over the past 4 months

- Not currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study

- No former participation in a study involving administration of iron stable isotopes

- No eating disorders or food allergy

- Subject who can be expected and are willing to comply with study protocol

- Having received oral and written information about the aims and procedures of the study

- Having provided oral and written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
FeSO4

reduction of phytate

NaFeEDTA


Locations

Country Name City State
Switzerland ETH Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Iron absorption Test meals with isotopic iron labels will be administrated on day 1-3. Whole blood samples will be collected on day 17 (14 after the last test meal) to analyze the iron isotope ratios. 17 days No
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