- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03586245
Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology
Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Suboptimal iron stores (Serum ferritin < 40 µg/L)
- BMI in range 18.5 - 24.9 kg/m2
- Willing to consumed meals containing iron supplement
- Willing to discontinue blood donation two weeks prior and during the study
- Willing to discontinue vitamin and mineral supplement use during the study
- Willing to provide a 15 ml blood for initial screening and 30 ml blood during the study (15 ml at each visit for 2 times in 24 days)
- Willing to attend 8 lab visits during the study
Exclusion Criteria:
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin < 120 g/L)
- Has gastrointestinal disease/condition that can affect absorption
- Vegetarian
- Allergic to corn, wheat, soybean nor fungal supplements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ferric pyrophosphate
Study I group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds.
Subjects received iron fortificants in a meal composed of zucchini, cabbage, carrot (42g each), onion (24g), corn oil (6.3 g), jasmine rice (75g dw), and flavored granulated chicken bouillon (6.6g). All meals were consumed in a fasted state with nothing to eat or drink (besides water) for 3 hours following consumption. |
57 Iron isotopically labeled FePP powder.
|
Experimental: Aspiron
The Aspiron group was required to follow the same protocol as the 57Fe as FePP, with the exception of consuming 58Fe ASP.
|
58 Iron isotope intrinsically labeled Aspergillus oryzae.
|
Other: Ferrous sulfate
The FeSO4 study group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. .
|
57 Iron isotopically labeled FeSO4 powder.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Fractional Iron absorption of FePP, FeS)4 and ASP
Time Frame: Whole blood collected 14 days following isotope consumption to allow for enrichment.
|
Isotope enrichment in the whole blood samples after 14 days of feeding the meals assuming 80% incorporation of iron into the hemoglobin.
Circulating iron was calculated from blood volume, height (cm), weight (kg) and hemoglobin (g/dL).
|
Whole blood collected 14 days following isotope consumption to allow for enrichment.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ASP Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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