Iron-deficiencyFe_GOS_1NCT03325270
Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores
A study testing labeled ferrous fumarate, labeled ferrous fumarate + prebiotics and labeled ferrous sulfate + prebiotics in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. 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?
- labeled ferrous fumarate, labeled ferrous fumarate + prebiotics and labeled ferrous sulfate + prebiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2018to 28 Apr 2018
- 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 <20 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, 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
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. It does not only affect large numbers of women and children in the developing world, but also in industrialized countries. The current estimation is that 2 billion people, or around 30% of the world's population, are anemic, of which around 50% is caused by iron deficiency. In industrialized countries, ID remains a public health concern in young women, affecting 16% of females between the ages of 12-49y in the United states.
Iron supplementation has been recommended by the WHO as an approach to improve iron status in varying age and risk groups. Iron supplementation can be practical for high-risk groups such as pregnant women and has been proven effective for increasing hemoglobin levels in women. However, iron absorption from supplements is generally low and epigastric side effects reduce compliance. With the high global burden of iron deficiency and anemia, improved products which allow better absorption and reduce side effects are urgently needed.
Targeted iron supplementation in high risk groups is the preferred way to treat iron deficiency. However, the recommendation is to consume iron supplements away from food in order to increase bioavailability which often causes nausea and epigastric pain and thus reduces compliance. Taken together with food, bioavailability of most supplements is reduced by about two thirds. Thus, a lot of unabsorbed iron passes into the colon where it can increase the abundance of enteropathogens.
Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. GOS are enzymatically produced from lactose and are a mixture of glucose- and galactose- based di- and oligosaccharides of varying structure and seem to have an increased selectivity towards Bifidobacterium spp compared to other prebiotics. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH, which may reduce growth of enteropathogens. 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, by reducing ferric to ferrous iron in the colon. Even though colonic absorption is minimal compared to absorption in the duodenum in healthy humans, it may become more important in iron deficiency or anemia as demonstrated in animal studies.
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.
- Conditions
- Iron-deficiency
- Being tested
- labeled ferrous fumarate, labeled ferrous fumarate + prebiotics, labeled ferrous sulfate + prebiotics
- Keywords
- prebiotics, Galacto-oligosaccharides, Iron-deficiency
- 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.
labeled ferrous fumarateDietary supplement
labeled iron as Ferrous Fumarate
labeled ferrous fumarate + prebioticsDietary supplement
labeled iron as Ferrous Fumarate + galacto-oligosaccharides
labeled ferrous sulfate + prebioticsDietary supplement
labeled iron as Ferrous Sulfate + galacto-oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| ferrous fumarate | Experimental | labeled iron as Ferrous Fumarate Receives: Dietary Supplement: labeled ferrous fumarate |
| ferrous fumarate and GOS | Experimental | labeled ferrous fumarate + prebiotics Receives: Dietary Supplement: labeled ferrous fumarate + prebiotics |
| ferrous sulfate and GOS | Experimental | labeled ferrous sulfate + prebiotics Receives: Dietary Supplement: labeled ferrous sulfate + prebiotics |
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 (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.
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 posted30 Oct 2017
- Study start10 Jan 2018
- Primary completion28 Apr 2018
- Study completion28 Apr 2018
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
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Burgerstein Vitamine
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael Zimmermann, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325270
- Sponsor's protocol ID
- Fe_GOS_1
- Acronym
- Fe_GOS_1
- Status last verified
- Jan 2019
- First submitted
- 25 Oct 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31004135
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores
- ClinicalTrials.gov ID
- NCT03325270
- Acronym / sponsor ID
- Fe_GOS_1 / Fe_GOS_1
- Conditions
- Iron-deficiency
- Keywords
- prebiotics, Galacto-oligosaccharides, Iron-deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Burgerstein Vitamine
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 28 Apr 2018 (actual)
- First posted
- 30 Oct 2017 (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.
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.
Detailed description
Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. It does not only affect large numbers of women and children in the developing world, but also in industrialized countries. The current estimation is that 2 billion people, or around 30% of the world's population, are anemic, of which around 50% is caused by iron deficiency. In industrialized countries, ID remains a public health concern in young women, affecting 16% of females between the ages of 12-49y in the United states.
Iron supplementation has been recommended by the WHO as an approach to improve iron status in varying age and risk groups. Iron supplementation can be practical for high-risk groups such as pregnant women and has been proven effective for increasing hemoglobin levels in women. However, iron absorption from supplements is generally low and epigastric side effects reduce compliance. With the high global burden of iron deficiency and anemia, improved products which allow better absorption and reduce side effects are urgently needed.
Targeted iron supplementation in high risk groups is the preferred way to treat iron deficiency. However, the recommendation is to consume iron supplements away from food in order to increase bioavailability which often causes nausea and epigastric pain and thus reduces compliance. Taken together with food, bioavailability of most supplements is reduced by about two thirds. Thus, a lot of unabsorbed iron passes into the colon where it can increase the abundance of enteropathogens.
Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. GOS are enzymatically produced from lactose and are a mixture of glucose- and galactose- based di- and oligosaccharides of varying structure and seem to have an increased selectivity towards Bifidobacterium spp compared to other prebiotics. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH, which may reduce growth of enteropathogens. 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, by reducing ferric to ferrous iron in the colon. Even though colonic absorption is minimal compared to absorption in the duodenum in healthy humans, it may become more important in iron deficiency or anemia as demonstrated in animal studies.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ferrous fumarate | Experimental | Dietary Supplement: labeled ferrous fumaratelabeled iron as Ferrous Fumarate |
| ferrous fumarate and GOS | Experimental | Dietary Supplement: labeled ferrous fumarate + prebioticslabeled ferrous fumarate + prebiotics |
| ferrous sulfate and GOS | Experimental | Dietary Supplement: labeled ferrous sulfate + prebioticslabeled ferrous sulfate + prebiotics |
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 <20 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 |
|---|---|---|
| labeled ferrous fumaratelabeled iron as Ferrous Fumarate | Dietary supplement | ferrous fumarate |
| labeled ferrous fumarate + prebioticslabeled iron as Ferrous Fumarate + galacto-oligosaccharides | Dietary supplement | ferrous fumarate and GOS |
| labeled ferrous sulfate + prebioticslabeled iron as Ferrous Sulfate + galacto-oligosaccharides | Dietary supplement | ferrous sulfate and GOS |
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 (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.
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 16 Jan 2019.
- Derived from this study: PubMed 31004135Jeroense 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.
- 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.
Michael Zimmermann, Prof. 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 labeled ferrous fumarate, labeled ferrous fumarate + prebiotics and labeled ferrous sulfate + prebiotics in people with Iron-deficiency, run by Swiss Federal Institute of Technology 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 16 Jan 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 NCT03325270, 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 16 Jan 2019.