Iron DeficiencyNCT02353325
Iron Bioavailability From Encapsulated Ferrous Sulphate
A study testing non-encapsulated FeSO4, encapsulated FeSO4, before cooking and encapsulated FeSO4, after cooking in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Salt is one of the very few regularly purchased food item in all socioeconomic classes including poor remote areas with subsistence farming. Therefore, it is a promising vehicle for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the burden of micronutrient deficiencies. 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?
- non-encapsulated FeSO4, encapsulated FeSO4, before cooking and encapsulated FeSO4, after cooking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Jun 2016
- 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 (ferritin < 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 (hemoglobin < 9.0 g/dL)
- Elevated C-reactive protein (> 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)
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- 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: Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
Salt is one of the very few regularly purchased food item in all socioeconomic classes including poor remote areas with subsistence farming. Therefore, it is a promising vehicle for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour change in fortified salt without significantly compromise bioavailability. In the present project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family (EPO).
- Conditions
- Iron Deficiency
- Being tested
- non-encapsulated FeSO4, encapsulated FeSO4, before cooking, encapsulated FeSO4, after cooking, non-encapsulated FeSO4 + ascorbic acid, encapsulated FeSO4 + ascorbic acid, before cooking
- Keywords
- Iron deficiency, Iron fortification, Iron encapsulation
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-encapsulated FeSO4Dietary supplement
encapsulated FeSO4, before cookingDietary supplement
encapsulated FeSO4, after cookingDietary supplement
non-encapsulated FeSO4 + ascorbic acidDietary supplement
encapsulated FeSO4 + ascorbic acid, before cookingDietary supplement
encapsulated FeSO4 + ascorbic acid, after cookingDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| non-encapsulated FeSO4 | Experimental | Maize porridge with salt fortified with non-encapsulated FeSO4 Receives: Dietary Supplement: non-encapsulated FeSO4 |
| encapsulated FeSO4, before cooking | Experimental | Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking Receives: Dietary Supplement: encapsulated FeSO4, before cooking |
| encapsulated FeSO4, after cooking | Experimental | Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking Receives: Dietary Supplement: encapsulated FeSO4, after cooking |
| non-encapsulated FeSO4 + ascorbic acid | Experimental | Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid Receives: Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid |
| encapsulated FeSO4 + ascorbic acid, before cooking | Experimental | Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking Receives: Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking |
| encapsulated FeSO4 + ascorbic acid, after cooking | Experimental | Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking Receives: Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionJun 2016
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
- 20 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
- NCT02353325
- Sponsor's protocol ID
- Omnisalt
- Status last verified
- Jun 2017
- First submitted
- 28 Jan 2015
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
- ClinicalTrials.gov ID
- NCT02353325
- Acronym / sponsor ID
- Omnisalt
- Conditions
- Iron Deficiency
- Keywords
- Iron deficiency, Iron fortification, Iron encapsulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- 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.
Salt is one of the very few regularly purchased food item in all socioeconomic classes including poor remote areas with subsistence farming. Therefore, it is a promising vehicle for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour change in fortified salt without significantly compromise bioavailability. In the present project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family (EPO).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| non-encapsulated FeSO4 | Experimental | Dietary Supplement: non-encapsulated FeSO4Maize porridge with salt fortified with non-encapsulated FeSO4 |
| encapsulated FeSO4, before cooking | Experimental | Dietary Supplement: encapsulated FeSO4, before cookingMaize porridge with salt fortified with non-encapsulated FeSO4, added before cooking |
| encapsulated FeSO4, after cooking | Experimental | Dietary Supplement: encapsulated FeSO4, after cookingMaize porridge with salt fortified with non-encapsulated FeSO4, added after cooking |
| non-encapsulated FeSO4 + ascorbic acid | Experimental | Dietary Supplement: non-encapsulated FeSO4 + ascorbic acidMaize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid |
| encapsulated FeSO4 + ascorbic acid, before cooking | Experimental | Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cookingMaize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking |
| encapsulated FeSO4 + ascorbic acid, after cooking | Experimental | Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cookingMaize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking |
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 (ferritin < 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 (hemoglobin < 9.0 g/dL)
- Elevated C-reactive protein (> 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 |
|---|---|---|
| non-encapsulated FeSO4 | Dietary supplement | non-encapsulated FeSO4 |
| encapsulated FeSO4, before cooking | Dietary supplement | encapsulated FeSO4, before cooking |
| encapsulated FeSO4, after cooking | Dietary supplement | encapsulated FeSO4, after cooking |
| non-encapsulated FeSO4 + ascorbic acid | Dietary supplement | non-encapsulated FeSO4 + ascorbic acid |
| encapsulated FeSO4 + ascorbic acid, before cooking | Dietary supplement | encapsulated FeSO4 + ascorbic acid, before cooking |
| encapsulated FeSO4 + ascorbic acid, after cooking | Dietary supplement | encapsulated FeSO4 + ascorbic acid, after cooking |
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.
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 12 Jun 2017.
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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.
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 non-encapsulated FeSO4, encapsulated FeSO4, before cooking and encapsulated FeSO4, after cooking 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 12 Jun 2017. 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 2 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 12 Jun 2017.