Iron-deficiencyNCT03332602
Iron Absorption From Encapsulated Iron Sulphate in Microspheres
A study testing free FeSO4, free FeSO4 and empty microspheres and free FeSO4 and hylauronic acid in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- free FeSO4, free FeSO4 and empty microspheres and free FeSO4 and hylauronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Apr 2018to 20 Aug 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18 to 40 years old
- Marginal iron status (PF <25 ng/ml)
- Body weight < 65 kg
- Normal body Mass Index (18.5 - 25 kg/m2)
- Signed informed consent
Who cannot join
- Pregnancy (assessed by a pregnancy test) / intention to become pregnant
- Lactating up to 6 weeks before study initiation
- Moderate or severe anaemia (Hb < 9.0 g/dL)
- Elevated C reactive Protein (CRP) (> 5.0 mg/L)
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives)
Show all 10Show fewer
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
- Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes.
Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.
- Conditions
- Iron-deficiency
- Being tested
- free FeSO4, free FeSO4 and empty microspheres, free FeSO4 and hylauronic acid, free FeSO4 and eudragit polymer, encapsulated FeSO4 3.2%
- Keywords
- Iron deficiency, Iron fortification, Iron encapsulation
- 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.
free FeSO4Dietary supplement
Testmeal with free FeSO4
free FeSO4 and empty microspheresDietary supplement
Testmeal with free FeSO4 and empty micropsheres
free FeSO4 and hylauronic acidDietary supplement
Testmeal with free FeSO4 and hyaluronic acid
free FeSO4 and eudragit polymerDietary supplement
Testmeal with free FeSO4 and eudragit polymer
encapsulated FeSO4 3.2%Dietary supplement
Testmeal with encapsulated FeSO4 with 3.2% Fe loading
encapsulated FeSO4 20%Dietary supplement
Testmeal with encapsulated FeSO4 with 20% Fe loading
encapsulated FeSO4 3.2%, encapsulated Vitamin ADietary supplement
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A
encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic AcidDietary supplement
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.
FeSO4 embedded in Hyaluronic acidDietary supplement
Testmeal with FeSO4 embedded in Hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| free FeSO4 | Experimental | wheat bread fortified with free FeSO4 Receives: Dietary Supplement: free FeSO4 |
| free FeSO4 and empty microspheres | Experimental | wheat bread fortified with free FeSO4, and empty microspheres Receives: Dietary Supplement: free FeSO4 and empty microspheres |
| free FeSO4 with eudragit polymer | Experimental | wheat bread fortified with free FeSO4, and eudragit polymer Receives: Dietary Supplement: free FeSO4 and eudragit polymer |
| free FeSO4 with Hyaluronic Acid | Experimental | wheat bread fortified with free FeSO4, and hyaluronic acid Receives: Dietary Supplement: free FeSO4 and hylauronic acid |
| encapsulated FeSO4 3.2% | Experimental | wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading Receives: Dietary Supplement: encapsulated FeSO4 3.2% |
| encapsulated FeSO4 20% | Experimental | wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading Receives: Dietary Supplement: encapsulated FeSO4 20% |
| encapsulated FeSO4 3.2%, encap. Vitamin A | Experimental | wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres Receives: Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A |
| encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid | Experimental | wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid Receives: Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid |
| FeSO4 embedded in Hyaluronic Acid | Experimental | wheat bread fortified with FeSO4 that is embedded in hyaluronic acid. Receives: Dietary Supplement: FeSO4 embedded in Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the isotopic ratio of iron in blood at week 2
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Measured: baseline, 2 weeks
Change from week 2 in the isotopic ratio of iron in blood at week 4
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Measured: 2 weeks, 4 weeks
Change from week 4 in the isotopic ratio of iron in blood at week 6
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Measured: 4 weeks, 6 weeks
Secondary outcomes (3)
Haemoglobin
Haemoglobin of each timepoint
Measured: baseline, weeks 2, 4 and 6
Plasma Ferritin
Plasma Ferritin of each timepoint
Measured: baseline, weeks 2, 4 and 6
inflammation marker
C reactive Protein of each timepoint
Measured: baseline, weeks 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start4 Apr 2018
- Primary completion18 Jul 2018
- Study completion20 Aug 2018
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332602
- Sponsor's protocol ID
- Omnifortificant
- Status last verified
- Aug 2018
- First submitted
- 18 Oct 2017
- Last updated
- 31 Aug 2018
- 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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
- ClinicalTrials.gov ID
- NCT03332602
- Acronym / sponsor ID
- Omnifortificant
- Conditions
- Iron-deficiency
- Keywords
- Iron deficiency, Iron fortification, Iron encapsulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 6 Nov 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.
Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes.
Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| free FeSO4 | Experimental | Dietary Supplement: free FeSO4wheat bread fortified with free FeSO4 |
| free FeSO4 and empty microspheres | Experimental | Dietary Supplement: free FeSO4 and empty microsphereswheat bread fortified with free FeSO4, and empty microspheres |
| free FeSO4 with eudragit polymer | Experimental | Dietary Supplement: free FeSO4 and eudragit polymerwheat bread fortified with free FeSO4, and eudragit polymer |
| free FeSO4 with Hyaluronic Acid | Experimental | Dietary Supplement: free FeSO4 and hylauronic acidwheat bread fortified with free FeSO4, and hyaluronic acid |
| encapsulated FeSO4 3.2% | Experimental | Dietary Supplement: encapsulated FeSO4 3.2%wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading |
| encapsulated FeSO4 20% | Experimental | Dietary Supplement: encapsulated FeSO4 20%wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading |
| encapsulated FeSO4 3.2%, encap. Vitamin A | Experimental | Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin Awheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres |
| encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid | Experimental | Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acidwheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid |
| FeSO4 embedded in Hyaluronic Acid | Experimental | Dietary Supplement: FeSO4 embedded in Hyaluronic acidwheat bread fortified with FeSO4 that is embedded in hyaluronic acid. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female, 18 to 40 years old
- Marginal iron status (PF <25 ng/ml)
- Body weight < 65 kg
- Normal body Mass Index (18.5 - 25 kg/m2)
- Signed informed consent
Key exclusion criteria (10 listed)
- Pregnancy (assessed by a pregnancy test) / intention to become pregnant
- Lactating up to 6 weeks before study initiation
- Moderate or severe anaemia (Hb < 9.0 g/dL)
- Elevated C reactive Protein (CRP) (> 5.0 mg/L)
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
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 |
|---|---|---|
| free FeSO4Testmeal with free FeSO4 | Dietary supplement | free FeSO4 |
| free FeSO4 and empty microspheresTestmeal with free FeSO4 and empty micropsheres | Dietary supplement | free FeSO4 and empty microspheres |
| free FeSO4 and hylauronic acidTestmeal with free FeSO4 and hyaluronic acid | Dietary supplement | free FeSO4 with Hyaluronic Acid |
| free FeSO4 and eudragit polymerTestmeal with free FeSO4 and eudragit polymer | Dietary supplement | free FeSO4 with eudragit polymer |
| encapsulated FeSO4 3.2%Testmeal with encapsulated FeSO4 with 3.2% Fe loading | Dietary supplement | encapsulated FeSO4 3.2% |
| encapsulated FeSO4 20%Testmeal with encapsulated FeSO4 with 20% Fe loading | Dietary supplement | encapsulated FeSO4 20% |
| encapsulated FeSO4 3.2%, encapsulated Vitamin ATestmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A | Dietary supplement | encapsulated FeSO4 3.2%, encap. Vitamin A |
| encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic AcidTestmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid. | Dietary supplement | encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid |
| FeSO4 embedded in Hyaluronic acidTestmeal with FeSO4 embedded in Hyaluronic acid | Dietary supplement | FeSO4 embedded in Hyaluronic Acid |
Primary outcome
Change from baseline in the isotopic ratio of iron in blood at week 2
Time frame: baseline, 2 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Change from week 2 in the isotopic ratio of iron in blood at week 4
Time frame: 2 weeks, 4 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Change from week 4 in the isotopic ratio of iron in blood at week 6
Time frame: 4 weeks, 6 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
3 secondary outcomes
Haemoglobin
Time frame: baseline, weeks 2, 4 and 6
Plasma Ferritin
Time frame: baseline, weeks 2, 4 and 6
inflammation marker
Time frame: baseline, weeks 2, 4 and 6
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 31 Aug 2018.
Related trials for Iron-deficiency
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruitingPhase 4
Iron Repletion in Cystic Fibrosis
Cystic Fibrosis, Iron Deficiencies
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free FeSO4, free FeSO4 and empty microspheres and free FeSO4 and hylauronic acid 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 10 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 31 Aug 2018. 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?
Change from baseline in the isotopic ratio of iron in blood at week 2 (time frame: baseline, 2 weeks). The study lists 3 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 31 Aug 2018.