Iron-deficiencyFe_GOS_2NCT03762148
Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
A study testing ferrous fumarate, ferrous sulphate and ferric pyrophosphate in people with Iron-deficiency, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- ferrous fumarate, ferrous sulphate and ferric pyrophosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2019to 11 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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 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
- Iron-deficiency
- Being tested
- ferrous fumarate, ferrous sulphate, ferric pyrophosphate, ferrous fumarate + 3.5 g GOS, ferrous fumarate + 7 g GOS
- Keywords
- iron-deficiency, prebiotics, galacto-oligosaccharides
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous fumarateDietary supplement
nutritional iron (14 mg) supplement in form of ferrous fumarate
ferrous sulphateDietary supplement
nutritional iron (14 mg) supplement in form of ferrous sulphate
ferric pyrophosphateDietary supplement
nutritional iron (14 mg) supplement in form of ferric pyrophosphate
ferrous fumarate + 3.5 g GOSDietary supplement
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)
ferrous fumarate + 7 g GOSDietary supplement
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)
ferrous sulphate + 15 g GOSDietary supplement
nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)
ferrous fumarate + Vitamin CDietary supplement
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C
ferric pyrophosphate + 15 g GOSDietary supplement
nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)
ferrous fumarate + 7 g GOS + Vitamin CDietary supplement
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C
| Study group | Role | What they receive |
|---|---|---|
| ferrous fumarate | Experimental | labelled iron as ferrous fumarate Receives: Dietary Supplement: ferrous fumarate |
| ferrous sulphate | Experimental | labelled iron as ferrous sulphate Receives: Dietary Supplement: ferrous sulphate |
| ferric pyrophosphate | Experimental | labelled iron as ferric pyrophosphate Receives: Dietary Supplement: ferric pyrophosphate |
| ferrous fumarate + 3.5 g GOS | Experimental | labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS Receives: Dietary Supplement: ferrous fumarate + 3.5 g GOS |
| ferrous fumarate + 7 g GOS | Experimental | labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS Receives: Dietary Supplement: ferrous fumarate + 7 g GOS |
| ferrous sulphate + 15 g GOS | Experimental | labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS Receives: Dietary Supplement: ferrous sulphate + 15 g GOS |
| ferrous fumarate + Vitamin C | Experimental | labelled iron as ferrous fumarate + Vitamin C Receives: Dietary Supplement: ferrous fumarate + Vitamin C |
| ferric pyrophosphate + 15 g GOS | Experimental | labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS Receives: Dietary Supplement: ferric pyrophosphate + 15 g GOS |
| ferrous fumarate + 7 g GOS + Vitamin C | Experimental | labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C Receives: Dietary Supplement: ferrous fumarate + 7 g GOS + Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Apr 2019
- Primary completion11 Jun 2019
- Study completion11 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Burgerstein Vitamine
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
- Investigators
- Isabelle Herter-Aeberli, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762148
- Sponsor's protocol ID
- Fe_GOS_2
- Acronym
- Fe_GOS_2
- Status last verified
- Jul 2019
- First submitted
- 30 Nov 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32692367
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03762148
- Acronym / sponsor ID
- Fe_GOS_2 / Fe_GOS_2
- Conditions
- Iron-deficiency
- Keywords
- iron-deficiency, prebiotics, galacto-oligosaccharides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Burgerstein Vitamine
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| ferrous fumarate | Experimental | Dietary Supplement: ferrous fumaratelabelled iron as ferrous fumarate |
| ferrous sulphate | Experimental | Dietary Supplement: ferrous sulphatelabelled iron as ferrous sulphate |
| ferric pyrophosphate | Experimental | Dietary Supplement: ferric pyrophosphatelabelled iron as ferric pyrophosphate |
| ferrous fumarate + 3.5 g GOS | Experimental | Dietary Supplement: ferrous fumarate + 3.5 g GOSlabelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS |
| ferrous fumarate + 7 g GOS | Experimental | Dietary Supplement: ferrous fumarate + 7 g GOSlabelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS |
| ferrous sulphate + 15 g GOS | Experimental | Dietary Supplement: ferrous sulphate + 15 g GOSlabelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS |
| ferrous fumarate + Vitamin C | Experimental | Dietary Supplement: ferrous fumarate + Vitamin Clabelled iron as ferrous fumarate + Vitamin C |
| ferric pyrophosphate + 15 g GOS | Experimental | Dietary Supplement: ferric pyrophosphate + 15 g GOSlabelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS |
| ferrous fumarate + 7 g GOS + Vitamin C | Experimental | Dietary Supplement: ferrous fumarate + 7 g GOS + Vitamin Clabelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferrous fumaratenutritional iron (14 mg) supplement in form of ferrous fumarate | Dietary supplement | ferrous fumarate |
| ferrous sulphatenutritional iron (14 mg) supplement in form of ferrous sulphate | Dietary supplement | ferrous sulphate |
| ferric pyrophosphatenutritional iron (14 mg) supplement in form of ferric pyrophosphate | Dietary supplement | ferric pyrophosphate |
| ferrous fumarate + 3.5 g GOSnutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS) | Dietary supplement | ferrous fumarate + 3.5 g GOS |
| ferrous fumarate + 7 g GOSnutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) | Dietary supplement | ferrous fumarate + 7 g GOS |
| ferrous sulphate + 15 g GOSnutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS) | Dietary supplement | ferrous sulphate + 15 g GOS |
| ferrous fumarate + Vitamin Cnutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C | Dietary supplement | ferrous fumarate + Vitamin C |
| ferric pyrophosphate + 15 g GOSnutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS) | Dietary supplement | ferric pyrophosphate + 15 g GOS |
| ferrous fumarate + 7 g GOS + Vitamin Cnutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C | Dietary supplement | ferrous fumarate + 7 g GOS + Vitamin C |
Primary outcome
fractional iron absorption
Time frame: 2 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Derived from this study: PubMed 32692367Jeroense 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Herter-Aeberli, Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferrous fumarate, ferrous sulphate and ferric pyrophosphate in people with Iron-deficiency, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fractional iron absorption (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.