Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
Fe_GOS_2
The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid
1 other identifier
interventional
46
1 country
1
Brief Summary
Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we 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 mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.
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 Apr 2019
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
November 30, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2019
CompletedJuly 25, 2019
July 1, 2019
2 months
November 30, 2018
July 24, 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.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 (9)
ferrous fumarate
EXPERIMENTALlabelled iron as ferrous fumarate
ferrous sulphate
EXPERIMENTALlabelled iron as ferrous sulphate
ferric pyrophosphate
EXPERIMENTALlabelled iron as ferric pyrophosphate
ferrous fumarate + 3.5 g GOS
EXPERIMENTALlabelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS
ferrous fumarate + 7 g GOS
EXPERIMENTALlabelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS
ferrous sulphate + 15 g GOS
EXPERIMENTALlabelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS
ferrous fumarate + Vitamin C
EXPERIMENTALlabelled iron as ferrous fumarate + Vitamin C
ferric pyrophosphate + 15 g GOS
EXPERIMENTALlabelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS
ferrous fumarate + 7 g GOS + Vitamin C
EXPERIMENTALlabelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C
Interventions
nutritional iron (14 mg) supplement in form of ferrous fumarate
nutritional iron (14 mg) supplement in form of ferrous sulphate
nutritional iron (14 mg) supplement in form of ferric pyrophosphate
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)
nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C
nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C
Eligibility Criteria
You may qualify if:
- Female, 18 to 45 years old
- SF levels \<30 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, 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Isabelle Herter-Aeberlilead
- Burgerstein Vitaminecollaborator
Study Sites (1)
Human Nutrition Laboratory, ETH Zurich
Zurich, 8092, Switzerland
Related Publications (1)
Jeroense FMD, Zeder C, Zimmermann MB, Herter-Aeberli I. Acute Consumption of Prebiotic Galacto-Oligosaccharides Increases Iron Absorption from Ferrous Fumarate, but not from Ferrous Sulfate and Ferric Pyrophosphate: Stable Iron Isotope Studies in Iron-Depleted Young Women. J Nutr. 2020 Sep 1;150(9):2391-2397. doi: 10.1093/jn/nxaa199.
PMID: 32692367DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle Herter-Aeberli, 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
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 30, 2018
First Posted
December 3, 2018
Study Start
April 1, 2019
Primary Completion
June 11, 2019
Study Completion
June 11, 2019
Last Updated
July 25, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share