Iron Deficiency AnemiaNCT02815449
Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women
A study testing Meals prepared with iron fortified cube with Low stabilizer level, Meals prepared with iron fortified cube with Medium stabilizer level and Meals prepared with iron fortified cube with High stabilizer level in people with Iron Deficiency Anemia, run by Unilever R&D at 1 site in Nigeria.
Trial summary
The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron fortification can be an effective strategy to decrease this. In the current study adding different levels of a stabilizer to iron fortified cubes and it's effect on iron bioavailability from these cubes will be studied in the context… 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 Anemia
- What is being tested?
- Meals prepared with iron fortified cube with Low stabilizer level, Meals prepared with iron fortified cube with Medium stabilizer level and Meals prepared with iron fortified cube with High stabilizer level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNigeria
- Study dates
- 8 May 2017to 24 Jul 2017
- 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
- Healthy female Nigerian subjects;
- Age > 18 and <40 years at screening;
- Body weight <65 kg;
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- With iron deficiency judged by a serum ferritin concentration of <15µg/L;
- Reported intense sporting activities ≤ 10h/w;
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- Reported alcohol consumption ≤ 14 units/w;
- Willing and able to participate in the study;
- Having given a written informed consent.
Who cannot join
- Being an employee of Unilever or the Department of Family, Nutrition and Consumer Science of the Obafemi Alowolo University;
- Blood donation or significant blood loss over the past 6 months;
- Being severely anemic (hemoglobin < 8.0 g/dL)
- Reported use of any medically- or self-prescribed diet;
- Use of vitamin or mineral supplements and unwillingness to discontinue their use one week prior the study and during the study;
- Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
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- Is pregnant or will be planning pregnancy during the study period;
- Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
- Known gastrointestinal (including helminth infection) or metabolic disorders;
- Participation in another clinical trial during the last 30 days prior to the beginning of the study;
- Symptomatic malaria (no blood smear analyses on malaria required)
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron fortification can be an effective strategy to decrease this.
In the current study adding different levels of a stabilizer to iron fortified cubes and it's effect on iron bioavailability from these cubes will be studied in the context of a Nigerian meal in women.
24 Female subjects with low serum ferritin levels will be included in the study. The study will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The absorption of iron will be evaluated after every period and compared between the cubes.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Meals prepared with iron fortified cube with Low stabilizer level, Meals prepared with iron fortified cube with Medium stabilizer level, Meals prepared with iron fortified cube with High stabilizer level
- Keywords
- Iron fortification, Bioavailability, Nigeria, Women, Bouillon cubes
- 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.
Meals prepared with iron fortified cube with Low stabilizer levelOther
Meals prepared with iron fortified cube with Low stabilizer level
Meals prepared with iron fortified cube with Medium stabilizer levelOther
Meals prepared with iron fortified cube with Medium stabilizer level
Meals prepared with iron fortified cube with High stabilizer levelOther
Meals prepared with iron fortified cube with High stabilizer level
| Study group | Role | What they receive |
|---|---|---|
| Low stabilizer level | Experimental | Meals prepared with iron fortified cube with low stabilizer level Receives: Other: Meals prepared with iron fortified cube with Low stabilizer level |
| Medium stabilizer level | Experimental | Meals prepared with iron fortified cube with medium stabilizer level Receives: Other: Meals prepared with iron fortified cube with Medium stabilizer level |
| High stabilizer level | Experimental | Meals prepared with iron fortified cube with high stabilizer level Receives: Other: Meals prepared with iron fortified cube with High stabilizer level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron isotopic composition of the blood at the end of each intervention period
The amount of iron isotopic label in the blood will be related to the low, medium and high stabilizer level in the cubes to determine whether a dose-response relationship exists.
Measured: 16 days
Secondary outcomes (1)
Iron isotopic composition of the blood
The amount of iron isotopic label in the blood at the end of each administration period plus 14 day incorporation time will be used to calculate the absolute Iron absorption for each stabilizer level
Measured: 1, 22, 43 and 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start8 May 2017
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
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 Deficiency AnemiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Obafemi Awolowo University
- Responsible party
- Sponsor
- Investigators
- Funke Olumakaiye, PhD, Principal investigator, Obafemi Awolowo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815449
- Sponsor's protocol ID
- FDS-SAV-2103
- Status last verified
- Jul 2017
- First submitted
- 24 May 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eilander A, Funke OM, Moretti D, Zimmermann MB, Owojuyigbe TO, Blonk C, Murray P, Duchateau GS. High Bioavailability from Ferric Pyrophosphate-Fortified Bouillon Cubes in Meals is Not Increased by Sodium Pyrophosphate: a Stable Iron Isotope Study in Young Nigerian Women. J Nutr. 2019 May 1;149(5):723-729. doi: 10.1093/jn/nxz003.
PubMed 31004134
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women
- ClinicalTrials.gov ID
- NCT02815449
- Acronym / sponsor ID
- FDS-SAV-2103
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron fortification, Bioavailability, Nigeria, Women, Bouillon cubes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Obafemi Awolowo University
- Study start
- 8 May 2017 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 28 Jun 2016 (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.
The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron fortification can be an effective strategy to decrease this.
In the current study adding different levels of a stabilizer to iron fortified cubes and it's effect on iron bioavailability from these cubes will be studied in the context of a Nigerian meal in women.
24 Female subjects with low serum ferritin levels will be included in the study. The study will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The absorption of iron will be evaluated after every period and compared between the cubes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low stabilizer level | Experimental | Other: Meals prepared with iron fortified cube with Low stabilizer levelMeals prepared with iron fortified cube with low stabilizer level |
| Medium stabilizer level | Experimental | Other: Meals prepared with iron fortified cube with Medium stabilizer levelMeals prepared with iron fortified cube with medium stabilizer level |
| High stabilizer level | Experimental | Other: Meals prepared with iron fortified cube with High stabilizer levelMeals prepared with iron fortified cube with high stabilizer level |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy female Nigerian subjects;
- Age > 18 and <40 years at screening;
- Body weight <65 kg;
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- With iron deficiency judged by a serum ferritin concentration of <15µg/L;
Key exclusion criteria (11 listed)
- Being an employee of Unilever or the Department of Family, Nutrition and Consumer Science of the Obafemi Alowolo University;
- Blood donation or significant blood loss over the past 6 months;
- Being severely anemic (hemoglobin < 8.0 g/dL)
- Reported use of any medically- or self-prescribed diet;
- Use of vitamin or mineral supplements and unwillingness to discontinue their use one week prior the study and during the study;
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 |
|---|---|---|
| Meals prepared with iron fortified cube with Low stabilizer levelMeals prepared with iron fortified cube with Low stabilizer level | Other | Low stabilizer level |
| Meals prepared with iron fortified cube with Medium stabilizer levelMeals prepared with iron fortified cube with Medium stabilizer level | Other | Medium stabilizer level |
| Meals prepared with iron fortified cube with High stabilizer levelMeals prepared with iron fortified cube with High stabilizer level | Other | High stabilizer level |
Primary outcome
Iron isotopic composition of the blood at the end of each intervention period
Time frame: 16 days
The amount of iron isotopic label in the blood will be related to the low, medium and high stabilizer level in the cubes to determine whether a dose-response relationship exists.
1 secondary outcome
Iron isotopic composition of the blood
Time frame: 1, 22, 43 and 64 days
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 1 Aug 2017.
- Derived from this study: PubMed 31004134Eilander A, Funke OM, Moretti D, Zimmermann MB, Owojuyigbe TO, Blonk C, Murray P, Duchateau GS. High Bioavailability from Ferric Pyrophosphate-Fortified Bouillon Cubes in Meals is Not Increased by Sodium Pyrophosphate: a Stable Iron Isotope Study in Young Nigerian Women. J Nutr. 2019 May 1;149(5):723-729. doi: 10.1093/jn/nxz003.
- Individual participant dataSharing planned: Undecided
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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.
Funke Olumakaiye, PhD principal investigator
Obafemi Awolowo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meals prepared with iron fortified cube with Low stabilizer level, Meals prepared with iron fortified cube with Medium stabilizer level and Meals prepared with iron fortified cube with High stabilizer level in people with Iron Deficiency Anemia, run by Unilever R&D at 1 site in Nigeria.
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 9 inclusion and 11 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 1 Aug 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 Nigeria. 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?
Iron isotopic composition of the blood at the end of each intervention period (time frame: 16 days). 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 NCT02815449, 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 1 Aug 2017.