- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03996421
Determination of Iron Absorption Mechanism From Ferrous Fumarate With GOS (Fe_GOS_3)
Determination of Iron Absorption Mechanism From Ferrous Fumarate With Galacto-oligosaccharides Using Stable Isotope Appearance Curves
Study Overview
Status
Conditions
Detailed Description
Iron is an important mineral in our body and fulfills essential functions such as for example oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. Common iron supplements all have their limitations in terms of availability and compatibility. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and they have been proposed to potentially improve iron absorption.
In a recent iron absorption study in adult women with low iron stores in the laboratory of human nutrition ETH zurich, it was found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study, the aim of the current study is to investigate the mechanism by which GOS acutely increases iron absorption by using stable isotope appearance curves. This will allow the evaluation of changes in serum iron isotopes over the first few hours after administration of the iron supplement and provides information where and in what amount iron absorption takes place in the GI-tract.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- Laboratory of Human Nutrition, ETH Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female, 18 to 45 years old
- SF levels 15-30 µg/L
- Normal body Mass Index (18.5-24.9 kg/m2)
- Body weight <70 kg
- Signed informed consent
Exclusion Criteria:
- Severe anaemia (Hb < 80 g/L)
- Elevated CRP >10.0 mg/L
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole studies (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Difficulties with blood sampling
- Use of antibiotics over the past month
- Known hypersensitivity to iron supplements in the given amount, GOS, or lactose
- Women who are pregnant or breast feeding
- Women who intend become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse -
- Smokers (> 1 cigarette per week)
- Inability to follow the procedures of the study, e.g. due to language problems, self-- reported psychological disorders, etc. of the participant
- Enrollment of the investigator, his/her family members, employees and other dependent persons
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: ferrous fumarate
labelled iron as ferrous fumarate
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nutritional iron (14 mg) supplement in form of ferrous fumarate
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EXPERIMENTAL: ferrous fumarate + 15 g GOS
labelled iron as ferrous fumarate + prebiotics in the form of 15 g GOS
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nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum iron isotope concentration
Time Frame: 29 days
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serum iron isotope concentration from ferrous fumarate with or without the addition of GOS at all the different time points.
Serum iron isotope concentration absorbed from the iron supplements will be calculated based on the shift of the iron isotope ratios in the collected blood samples at least 14 days after the last administration of the isotopically labelled supplements.The iron isotope ratios in the collected blood samples will be measured using an ICP-mass spectrometry instrument (NEPTUNE, Thermo Finnigan).
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29 days
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total fractional iron absorption
Time Frame: 29 days
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total iron fractional absorption from ferrous fumarate with or without the addition of GOS at all the different time points.
Fractional absorption of iron (%) from the iron supplements will be calculated based on the shift of the iron isotope ratios in the collected blood samples at least 14 days after the last administration of the isotopically labelled supplements.The iron isotope ratios in the collected blood samples will be measured using an ICP-mass spectrometry instrument (NEPTUNE, Thermo Finnigan).
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29 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Haemoglobin (Hb)
Time Frame: 29 days
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Haemoglobin (Hb) (g/L)
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29 days
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serum ferritin (SF)
Time Frame: 29 days
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serum ferritin (SF) (microg/L)
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29 days
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serum transferrin receptor (sTfR)
Time Frame: 29 days
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serum transferrin receptor (sTfR) (mg)L)
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29 days
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alpha-1-acid glycoprotein (AGP)
Time Frame: 29 days
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alpha-1-acid glycoprotein (AGP) (g/L)
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29 days
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C - reactive protein (CRP)
Time Frame: 29 days
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C - reactive protein (CRP) (mg/L)
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29 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Isabelle Herter-Aeberli, Dr., Laboratory of Human Nutrition ETH Zürich
Publications and helpful links
General Publications
- Jeroense FMD, Michel L, Zeder C, Herter-Aeberli I, Zimmermann MB. Consumption of Galacto-Oligosaccharides Increases Iron Absorption from Ferrous Fumarate: A Stable Iron Isotope Study in Iron-Depleted Young Women. J Nutr. 2019 May 1;149(5):738-746. doi: 10.1093/jn/nxy327.
- Husmann FMD, Stierli L, Bram DS, Zeder C, Kramer SD, Zimmermann MB, Herter-Aeberli I. Kinetics of iron absorption from ferrous fumarate with and without galacto-oligosaccharides determined from stable isotope appearance curves in women. Am J Clin Nutr. 2022 Mar 4;115(3):949-957. doi: 10.1093/ajcn/nqab361.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fe_GOS_3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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