Iron Absorption From Tef-injera in Women of Reproductive Age
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Purpose
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 three different ways, by improved fermentation with selected microorganisms, 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.
| Condition | Intervention |
|---|---|
|
Iron Deficiency |
Other: FeSO4 Other: reduction of phytate Other: NaFeEDTA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Iron Absorption From Tef-injera in Women of Reproductive Age |
- Iron absorption [ Time Frame: 17 days ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 54 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | May 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: FeSO4 + high phytate
injera test meal 1 labeled with a 4 mg staple iron isotope tag
|
Other: FeSO4 |
|
Experimental: FeSO4 + medium phytate 1
injera test meal 2 labeled with a 4 mg staple iron isotope tag
|
Other: FeSO4 Other: reduction of phytate |
|
Experimental: FeSO4 + medium phytate 2
injera test meal 3 labeled with a 4 mg staple iron isotope tag
|
Other: FeSO4 Other: reduction of phytate |
|
Experimental: FeSO4 + low phytate
injera test meal 4 labeled with a 4 mg staple iron isotope tag
|
Other: FeSO4 Other: reduction of phytate |
|
Experimental: FeSO4 + NaFeEDTA (1:1) + high phytate
injera test meal 5 labeled with a 4 mg staple iron isotope tag
|
Other: FeSO4 Other: NaFeEDTA |
|
Experimental: FeSO4 + NaFeEDTA (1:3) + high phytate
injera test meal 6 labeled with a 4 mg staple iron isotope tag
|
Other: FeSO4 Other: NaFeEDTA |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of Technology |
| ClinicalTrials.gov Identifier: | NCT01687062 History of Changes |
| Other Study ID Numbers: | EK2012N31 |
| Study First Received: | September 13, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by Swiss Federal Institute of Technology:
|
NaFeEDTA phytate injera iron absorption |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases Iron Fe(III)-EDTA |
Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013