Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores
Fe_GOS_1
1 other identifier
interventional
46
1 country
1
Brief Summary
Rationale: According to the WHO, iron deficiency is still the most common and widespread nutritional disorder in the world. Current iron supplements have limitations in terms of bioavailability and tolerability. 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 colonic pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and they have been proposed to potentially improve iron absorption as well. The primary objective of this study is to investigate the effect of an addition of GOS to an iron supplement on iron absorption in iron deplete, healthy, normal weight women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2017
CompletedFirst Posted
Study publicly available on registry
October 30, 2017
CompletedStudy Start
First participant enrolled
January 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2018
CompletedJanuary 16, 2019
January 1, 2019
4 months
October 25, 2017
January 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fractional iron absorption
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements (days 0, 2 16, 18, 20, 37, 39, 41).Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
2 months
Study Arms (3)
ferrous fumarate
EXPERIMENTALlabeled iron as Ferrous Fumarate
ferrous fumarate and GOS
EXPERIMENTALlabeled ferrous fumarate + prebiotics
ferrous sulfate and GOS
EXPERIMENTALlabeled ferrous sulfate + prebiotics
Interventions
labeled iron as Ferrous Fumarate + galacto-oligosaccharides
labeled iron as Ferrous Sulfate + galacto-oligosaccharides
Eligibility Criteria
You may qualify if:
- Female, 18 to 45 years old
- SF levels \<20 µg/L
- Normal body Mass Index (18.5-24.9 kg/m2)
- Body weight \<70 kg
- Signed informed consent
You may not qualify if:
- 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, injectable, 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss Federal Institute of Technologylead
- Burgerstein Vitaminecollaborator
Study Sites (1)
ETH Zurich
Zurich, 8092, Switzerland
Related Publications (1)
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.
PMID: 31004135DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Zimmermann, Prof. Dr.
University of Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Laboratory of Human Nutrition
Study Record Dates
First Submitted
October 25, 2017
First Posted
October 30, 2017
Study Start
January 10, 2018
Primary Completion
April 28, 2018
Study Completion
April 28, 2018
Last Updated
January 16, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share