Assessment of Iron Absorption From Aspergillus Oryzae

Iron Bioavailability Clinical Trial

Official title:

Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156725
• Other study ID #: HIFS study
• Status: Completed
• Phase: N/A
• First received: May 12, 2017
• Last updated: May 15, 2017
• Start date: May 19, 2014
• Est. completion date: June 4, 2016

Study information

• Verified date: May 2017
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 4, 2016
• Est. primary completion date: September 14, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Iron Bioavailability

Intervention

Drug:
• Ferrous Sulfate

Dietary Supplement:
• Aspiron

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iowa State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iron absorption	Isotope enrichment in the blood samples	15 days
Secondary	iron status	hepcidin and ferritin	15 days