NCT Number: NCT03156725
Assessment of Iron Absorption From Aspergillus Oryzae
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.
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Notify MeKey information
Conditions
Age range
18 year–35 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Marginal iron status (Serum ferritin <30ug/L)
- BMI in the range 18.5-24.9 kg/m2
- Willing to discontinue vitamin and mineral supplements 2 weeks prior and during the study
- Willing to consume stable iron isotope labelled supplement
- Willing to stop getting blood drawn 2 weeks prior to the study and during the study
- Willing to give multiple blood samples at beginning and end of study
Exclusion criteria
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin < 120 g/L)
- Has gastro-intestinal disease/condition that can affect absorption
- Allergic to any of the meal components
Treatment and study plan
Aspiron
Dietary SupplementPrimary outcomes
-
iron absorption
Time frame: 15 days
Isotope enrichment in the blood samples
Secondary outcomes
-
iron status
Time frame: 15 days
hepcidin and ferritin
Sponsors and collaborators
Lead sponsor
Iowa State University
Other
Registry information
Official study title
Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2016
- First posted
- May 17, 2017
- Registry last updated
- May 17, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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