Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
NCT ID: NCT03762148
Last Updated: 2019-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
46 participants
INTERVENTIONAL
2019-04-01
2019-06-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores
NCT03325270
The Effect of Different Prebiotics on Iron Absorption From High Dose Iron Supplements
NCT04194255
Determination of Iron Absorption Mechanism From Ferrous Fumarate With GOS
NCT03996421
Fermented Iron-rich Supplement in Reducing Anemia
NCT02037724
Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)
NCT02666417
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ferrous fumarate
labelled iron as ferrous fumarate
ferrous fumarate
nutritional iron (14 mg) supplement in form of ferrous fumarate
ferrous sulphate
labelled iron as ferrous sulphate
ferrous sulphate
nutritional iron (14 mg) supplement in form of ferrous sulphate
ferric pyrophosphate
labelled iron as ferric pyrophosphate
ferric pyrophosphate
nutritional iron (14 mg) supplement in form of ferric pyrophosphate
ferrous fumarate + 3.5 g GOS
labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS
ferrous fumarate + 3.5 g GOS
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)
ferrous fumarate + 7 g GOS
labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS
ferrous fumarate + 7 g GOS
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)
ferrous sulphate + 15 g GOS
labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS
ferrous sulphate + 15 g GOS
nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)
ferrous fumarate + Vitamin C
labelled iron as ferrous fumarate + Vitamin C
ferrous fumarate + Vitamin C
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C
ferric pyrophosphate + 15 g GOS
labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS
ferric pyrophosphate + 15 g GOS
nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)
ferrous fumarate + 7 g GOS + Vitamin C
labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C
ferrous fumarate + 7 g GOS + Vitamin C
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ferrous fumarate
nutritional iron (14 mg) supplement in form of ferrous fumarate
ferrous sulphate
nutritional iron (14 mg) supplement in form of ferrous sulphate
ferric pyrophosphate
nutritional iron (14 mg) supplement in form of ferric pyrophosphate
ferrous fumarate + 3.5 g GOS
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)
ferrous fumarate + 7 g GOS
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)
ferrous sulphate + 15 g GOS
nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)
ferrous fumarate + Vitamin C
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C
ferric pyrophosphate + 15 g GOS
nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)
ferrous fumarate + 7 g GOS + Vitamin C
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* SF levels \<30 µg/L
* Normal body Mass Index (18.5-24.9 kg/m2)
* Body weight \<70 kg
* Signed informed consent
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Burgerstein Vitamine
INDUSTRY
Isabelle Herter-Aeberli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Isabelle Herter-Aeberli
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabelle Herter-Aeberli, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Human Nutrition Laboratory, ETH Zurich
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Fe_GOS_2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.