Iron-deficiencyNCT05414474
Effects of Enhancers and Inhibitors on Absorption From Iron Supplements
A study testing Reference, Ascorbic acid (AA) 500 mg and Ascorbic acid (AA) 80 mg in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia
- What is being tested?
- Reference, Ascorbic acid (AA) 500 mg and Ascorbic acid (AA) 80 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jun 2022to 9 Dec 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18 to 45 years old,
- SF levels <30 μg/L,
- Body weight < 70 kg
- Normal Body Mass Index (18.5-25 kg/m2),
- Signed informed consent.
Who cannot join
- Anemia (Hb < 12 g/dL)
- Elevated CRP > 5 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) affecting iron metabolism,
- Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism,
- Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection,
- Difficulties with blood sampling,
Show all 14Show fewer
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
- Known hypersensitivity or allergy to iron capsules in the given amount (ferrous fumarate, brilliant blue FCF (E133), titandioxide (E171) and sodium lauryl sulfate)
- Pregnancy, breastfeeding
- Women who intend to become pregnant during the course of the study,
- Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse,
- Smokers (> 1 cigarette per week),
- Participant is likely to be absent on one the study appointments,
- Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health
Zurich, 8092
About this study
Official title: Effects of Nutritional Iron Absorption Enhancers and Inhibitors and Daytime on Absorption From Oral Iron Supplements
Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are recommended to be taken on an empty stomach in the morning and without a meal to avoid any interaction with phytic acid, another iron absorption inhibitor present in many foods. However, the effects of these iron absorption enhancers and inhibitors have only been shown on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin increase on absorption from an iron supplement given in the afternoon without a preceding morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon decreases iron bioavailability from a supplemental dose is uncertain.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Being tested
- Reference, Ascorbic acid (AA) 500 mg, Ascorbic acid (AA) 80 mg, Coffee, Breakfast
- Keywords
- iron supplementation, women of reproductive age, iron absorption enhancers, iron absorption inhibitors, ferrous fumarate, iron deficiency
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReferenceOther
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes
Ascorbic acid (AA) 500 mgOther
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 500 mg AA
Ascorbic acid (AA) 80 mgOther
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe + 80 mg AA
CoffeeOther
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes + 150 mL coffee
BreakfastOther
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 1 bread roll (~100 g) with butter and honey + 1 cup of plain yoghurt (180 mL) + 1 cup of coffee (150 mL) + 1 glass of orange juice (250 mL)
AfternoonOther
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe isotopes administered in the afternoon
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe). Receives: Other: Reference |
| Ascorbic acid (AA) 500 mg | Experimental | Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 500 mg AA. Receives: Other: Ascorbic acid (AA) 500 mg |
| Ascorbic acid (AA) 80 mg | Experimental | Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) and 80 mg AA. Receives: Other: Ascorbic acid (AA) 80 mg |
| Coffee | Experimental | Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe) and 150 mL coffee. Receives: Other: Coffee |
| Breakfast | Experimental | Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 1 bread roll (~100 g) with butter and honey, 1 cup of plain yoghurt (180 mL), 1 cup of coffee (150 mL) and 1 glass of orange juice (250 mL). Receives: Other: Breakfast |
| Afternoon | Experimental | Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) in the afternoon . Receives: Other: Afternoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption [percent]
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. 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: Day 22
Fractional iron absorption [percent]
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. 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: Day 43
Total iron absorption [mg]
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Measured: Day 22
Total iron absorption [mg]
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Measured: Day 43
Secondary outcomes (8)
Hemoglobin (Hb)
Iron status marker
Measured: Day 1, 22, 26 and 43
Serum ferritin (SF)
Iron status marker
Measured: Day 1, 22, 26 and 43
Serum transferrin receptor (sTfR)
Iron status marker
Measured: Day 1, 22, 26 and 43
Serum iron (SFe)
Iron status marker
Measured: Day 1, 22, 26 and 43
Total iron binding capacity (TIBC)
Iron status marker
Measured: Day 1, 22, 26 and 43
Hepcidin
Iron regulatory protein
Measured: Day 1, 22 and 26
C-reactive protein (CRP)
Inflammation marker
Measured: Day 1, 22, 26 and 43
Alpha-1-acid-glycoprotein (AGP)
Inflammation marker
Measured: Day 1, 22, 26 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start20 Jun 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Stoffel, Dr., Principal investigator, Human Nutrition Laboratory, ETH Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414474
- Sponsor's protocol ID
- IDEA
- Status last verified
- Jan 2024
- First submitted
- 13 May 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Iron Absorption Enhancers and Inhibitors and Daytime on Absorption From Oral Iron Supplements
- ClinicalTrials.gov ID
- NCT05414474
- Acronym / sponsor ID
- IDEA
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Keywords
- iron supplementation, women of reproductive age, iron absorption enhancers, iron absorption inhibitors, ferrous fumarate, iron deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 10 Jun 2022 (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 (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are recommended to be taken on an empty stomach in the morning and without a meal to avoid any interaction with phytic acid, another iron absorption inhibitor present in many foods. However, the effects of these iron absorption enhancers and inhibitors have only been shown on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin increase on absorption from an iron supplement given in the afternoon without a preceding morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon decreases iron bioavailability from a supplemental dose is uncertain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Other: ReferenceFerrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe). |
| Ascorbic acid (AA) 500 mg | Experimental | Other: Ascorbic acid (AA) 500 mgFerrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 500 mg AA. |
| Ascorbic acid (AA) 80 mg | Experimental | Other: Ascorbic acid (AA) 80 mgFerrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) and 80 mg AA. |
| Coffee | Experimental | Other: CoffeeFerrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe) and 150 mL coffee. |
| Breakfast | Experimental | Other: BreakfastFerrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 1 bread roll (~100 g) with butter and honey, 1 cup of plain yoghurt (180 mL), 1 cup of coffee (150 mL) and 1 glass of orange juice (250 mL). |
| Afternoon | Experimental | Other: AfternoonFerrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) in the afternoon . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female, 18 to 45 years old,
- SF levels <30 μg/L,
- Body weight < 70 kg
- Normal Body Mass Index (18.5-25 kg/m2),
- Signed informed consent.
Key exclusion criteria (14 listed)
- Anemia (Hb < 12 g/dL)
- Elevated CRP > 5 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) affecting iron metabolism,
- Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism,
- Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection,
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 |
|---|---|---|
| ReferenceFerrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes | Other | Reference |
| Ascorbic acid (AA) 500 mgFerrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 500 mg AA | Other | Ascorbic acid (AA) 500 mg |
| Ascorbic acid (AA) 80 mgFerrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe + 80 mg AA | Other | Ascorbic acid (AA) 80 mg |
| CoffeeFerrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes + 150 mL coffee | Other | Coffee |
| BreakfastFerrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 1 bread roll (~100 g) with butter and honey + 1 cup of plain yoghurt (180 mL) + 1 cup of coffee (150 mL) + 1 glass of orange juice (250 mL) | Other | Breakfast |
| AfternoonFerrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe isotopes administered in the afternoon | Other | Afternoon |
Primary outcome
Fractional iron absorption [percent]
Time frame: Day 22
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Fractional iron absorption [percent]
Time frame: Day 43
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Total iron absorption [mg]
Time frame: Day 22
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Total iron absorption [mg]
Time frame: Day 43
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
8 secondary outcomes
Hemoglobin (Hb)
Time frame: Day 1, 22, 26 and 43
Serum ferritin (SF)
Time frame: Day 1, 22, 26 and 43
Serum transferrin receptor (sTfR)
Time frame: Day 1, 22, 26 and 43
Serum iron (SFe)
Time frame: Day 1, 22, 26 and 43
Total iron binding capacity (TIBC)
Time frame: Day 1, 22, 26 and 43
Hepcidin
Time frame: Day 1, 22 and 26
C-reactive protein (CRP)
Time frame: Day 1, 22, 26 and 43
Alpha-1-acid-glycoprotein (AGP)
Time frame: Day 1, 22, 26 and 43
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 Jan 2024.
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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.
Nicole Stoffel, Dr. principal investigator
Human Nutrition Laboratory, ETH Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference, Ascorbic acid (AA) 500 mg and Ascorbic acid (AA) 80 mg in people with Iron-deficiency and Iron Deficiency Anemia, 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 14 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 Jan 2024. 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 [percent] (time frame: Day 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.