Anemia; Deficiency, Nutritional, With Poor Iron AbsorptionFe_SenegalNCT02437955
Fe Absorption in Mother and Child Pairs From Wheat Fortified With Iron With and Without Phenolic Containing Beverages
A study testing Ferrous sulfate fortified bread with tea, ferrous sulfate fortified bread with water and Ferrous fumarate fortified bread with tea in people with Anemia; Deficiency, Nutritional, With Poor Iron Absorption, run by Swiss Federal Institute of Technology at 1 site in Senegal.
Trial summary
In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50 months indicating that iron deficiency is a major health problem. The government of Senegal has implemented a flour fortification program including iron and folate. Read more about this study
- Who is it for?
- Ages 3 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia; Deficiency, Nutritional, With Poor Iron Absorption
- What is being tested?
- Ferrous sulfate fortified bread with tea, ferrous sulfate fortified bread with water and Ferrous fumarate fortified bread with tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSenegal
- Study dates
- Apr 2015to Oct 2015
- 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 3 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mother and child are willing to participate in the study jointly
- Specific inclusions criteria for mothers
- Body weight < 65 kg
- 17 ≤ BMI ≤ 25 (kg/m2)
- Non anemic (Hb ≥ 11,0 g/dl)
- Generally healthy and no chronic illnesses
Show all 13Show fewer
- Non pregnant
- Non lactating
- No blood donation in the last 4 months
- No consumption of vitamin and nutritional supplements during and 2 weeks prior the study start.
- Age 3-6 years
- Generally healthy and no chronic illnesses
- no consumption of vitamin and mineral supplements during and 2 weeks prior the study start
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the National Fortification Policy in Senegal Assessment of Iron Bio-availability in Mother and Child Pairs From Wheat Flour Fortified With Iron With and Without Phenolic Containing Beverages
In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50 months indicating that iron deficiency is a major health problem. The government of Senegal has implemented a flour fortification program including iron and folate. Iron is a difficult mineral to add to foods efficiently due to its organoleptic properties and typical low bioavailability in man. The aim of this study is to determine iron absorption from fortified wheat flour consumed with a phenolic containing beverage in women and child pairs. The fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly investigated.
The bioavailability of the different iron compounds will be determined using stable iron isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women between 18-45y) will be selected for participation in the study. After a screening, each women and child will receive 4 test meals consisting of a bread roll fortified stable isotopes with and without the tisane beverage. The first two test meals will be consumed on consecutive days. Two weeks after the second test meal a blood sample will be taken from each women and child before the third meal administration. After the forth test meal administration, and again two weeks later, the last blood sampling will take place and the study will be conducted for the subjects (duration 30 days). The samples will be sent to Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as well as inflammation status (CRP) will be determined.
Read the detailed description
In this study each subject will act as his own control and receive all interventions. Iron absorption data from the different test meals will be therefore compared assessing within and subject effects (main outcomes). Secondary outcomes will also investigate between subject effects and co variates of iron absorption.
- Being tested
- Ferrous sulfate fortified bread with tea, ferrous sulfate fortified bread with water, Ferrous fumarate fortified bread with tea, Ferrous fumarate fortified bread with water
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfate fortified bread with teaOther
Fasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes
ferrous sulfate fortified bread with waterOther
Fasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes
Ferrous fumarate fortified bread with teaOther
Fasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes
Ferrous fumarate fortified bread with waterOther
Fasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes
| Study group | Role | What they receive |
|---|---|---|
| FESO4+T | Experimental | Ferrous sulfate fortified bread with tea Receives: Other: Ferrous sulfate fortified bread with tea |
| FESO4+W | Experimental | Ferrous sulfate fortified bread with water Receives: Other: ferrous sulfate fortified bread with water |
| FeFu+T | Experimental | Ferrous fumarate fortified bread with tea Receives: Other: Ferrous fumarate fortified bread with tea |
| FeFu+W | Experimental | Ferrous fumarate fortified bread with water Receives: Other: Ferrous fumarate fortified bread with water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron absorption measured as iron incorporation of stable isotopic labels in red blood cells 14 days after administration
The effect of the consumption of tea (phenolic containing beverages) will be assessed the two iron fortification compounds. The interaction between beverage and compound on iron absorption will be tested. The analysis will be separately conducted for mothers and children.
Measured: Up to 8 Months after study start
Secondary outcomes (1)
Correlation between iron absorption in mother and child pairs
The correlation of iron absorption from the different test meals between in mother and child pairs will be assessed. A variable will be defined which will consist of the difference in iron absorption between each mother and child, within one mother child pair cluster. Determinants of this variable will be explored by linear regression, such as iron status, parity, age, gender, anthropometry, iron status, vitamin status (A, B2, B12, folate) h. pylori test and hepcidin.
Measured: Up to 8 Months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia; Deficiency, Nutritional, With Poor Iron AbsorptionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Cheikh Anta Diop University, Senegal
- Responsible party
- Sponsor
- Investigators
- Ndeye Fatou Ndiaye, PhD, Principal investigator, Université Cheikh Anta Diop de Dakar, Sengal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437955
- Sponsor's protocol ID
- EK 2014-N-37
- Acronym
- Fe_Senegal
- Status last verified
- Nov 2015
- First submitted
- 15 Apr 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the National Fortification Policy in Senegal Assessment of Iron Bio-availability in Mother and Child Pairs From Wheat Flour Fortified With Iron With and Without Phenolic Containing Beverages
- ClinicalTrials.gov ID
- NCT02437955
- Acronym / sponsor ID
- Fe_Senegal / EK 2014-N-37
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Cheikh Anta Diop University, Senegal
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 May 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.
In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50 months indicating that iron deficiency is a major health problem. The government of Senegal has implemented a flour fortification program including iron and folate. Iron is a difficult mineral to add to foods efficiently due to its organoleptic properties and typical low bioavailability in man. The aim of this study is to determine iron absorption from fortified wheat flour consumed with a phenolic containing beverage in women and child pairs. The fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly investigated.
The bioavailability of the different iron compounds will be determined using stable iron isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women between 18-45y) will be selected for participation in the study. After a screening, each women and child will receive 4 test meals consisting of a bread roll fortified stable isotopes with and without the tisane beverage. The first two test meals will be consumed on consecutive days. Two weeks after the second test meal a blood sample will be taken from each women and child before the third meal administration. After the forth test meal administration, and again two weeks later, the last blood sampling will take place and the study will be conducted for the subjects (duration 30 days). The samples will be sent to Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as well as inflammation status (CRP) will be determined.
Detailed description
In this study each subject will act as his own control and receive all interventions. Iron absorption data from the different test meals will be therefore compared assessing within and subject effects (main outcomes). Secondary outcomes will also investigate between subject effects and co variates of iron absorption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FESO4+T | Experimental | Other: Ferrous sulfate fortified bread with teaFerrous sulfate fortified bread with tea |
| FESO4+W | Experimental | Other: ferrous sulfate fortified bread with waterFerrous sulfate fortified bread with water |
| FeFu+T | Experimental | Other: Ferrous fumarate fortified bread with teaFerrous fumarate fortified bread with tea |
| FeFu+W | Experimental | Other: Ferrous fumarate fortified bread with waterFerrous fumarate fortified bread with water |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Mother and child are willing to participate in the study jointly
- Specific inclusions criteria for mothers
- Body weight < 65 kg
- 17 ≤ BMI ≤ 25 (kg/m2)
- Non anemic (Hb ≥ 11,0 g/dl)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ferrous sulfate fortified bread with teaFasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes | Other | FESO4+T |
| ferrous sulfate fortified bread with waterFasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes | Other | FESO4+W |
| Ferrous fumarate fortified bread with teaFasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes | Other | FeFu+T |
| Ferrous fumarate fortified bread with waterFasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes | Other | FeFu+W |
Primary outcome
Iron absorption measured as iron incorporation of stable isotopic labels in red blood cells 14 days after administration
Time frame: Up to 8 Months after study start
The effect of the consumption of tea (phenolic containing beverages) will be assessed the two iron fortification compounds. The interaction between beverage and compound on iron absorption will be tested. The analysis will be separately conducted for mothers and children.
1 secondary outcome
Correlation between iron absorption in mother and child pairs
Time frame: Up to 8 Months after study start
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 30 Nov 2015.
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.
Ndeye Fatou Ndiaye, PhD principal investigator
Université Cheikh Anta Diop de Dakar, Sengal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous sulfate fortified bread with tea, ferrous sulfate fortified bread with water and Ferrous fumarate fortified bread with tea in people with Anemia; Deficiency, Nutritional, With Poor Iron Absorption, run by Swiss Federal Institute of Technology at 1 site in Senegal.
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 13 inclusion and 0 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 30 Nov 2015. 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 Senegal. 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 absorption measured as iron incorporation of stable isotopic labels in red blood cells 14 days after administration (time frame: Up to 8 Months after study start). 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 30 Nov 2015.