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Completed

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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Key information

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

Ferrous Sulfate

Drug

Aspiron

Dietary Supplement

Primary outcomes

  1. iron absorption

    Time frame: 15 days

    Isotope enrichment in the blood samples

Secondary outcomes

  1. 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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