Trials / Completed
CompletedNCT03156725
Assessment of Iron Absorption From Aspergillus Oryzae
Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Iowa State University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.
Detailed description
Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value \<30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferrous Sulfate | |
| DIETARY_SUPPLEMENT | Aspiron |
Timeline
- Start date
- 2014-05-19
- Primary completion
- 2014-09-14
- Completion
- 2016-06-04
- First posted
- 2017-05-17
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT03156725. Inclusion in this directory is not an endorsement.