Anemia, Iron-DeficiencyFeGOSNCT02666417
Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)
A study testing Fortified maize porridge (MNP+iron) and Fortified maize porridge (MNP+iron+GOS) in people with Anemia, Iron-Deficiency, run by Swiss Federal Institute of Technology at 1 site in Kenya.
Trial summary
Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. Read more about this study
- Who is it for?
- Ages 6 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-Deficiency
- What is being tested?
- Fortified maize porridge (MNP+iron) and Fortified maize porridge (MNP+iron+GOS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2016to Dec 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 6 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of 6-14 months at baseline
- Assessment of good health as assessed by professional staff at Msambweni District Hospital
- Willingness of their caregiver to provide informed consent
Who cannot join
- Hemoglobin <70 g/L ; these infants will be referred for treatment according to local standard of care.
- Severe underweight (Z-score weight-for-age <-3) and /or severe wasting (Z-score weight-for-height<-3)
- Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- Participants taking part in other studies requiring the drawing of blood
- Participants who are taking iron-containing food supplements or tablets/drops
- Participants who are taking antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa
Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. The investigators recently finished a randomized, double blind controlled intervention trial in Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement the intervention study, the present study will compare iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. A stool sample will be collected at baseline and on the first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron absorption from the iron and GOS containing MNP will inform decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still cover the infant requirement for absorbed iron.
Read the detailed description
Iron absorption from two iron-fortified maize-based test meals will be measured in two groups of 40 infants (total N=80). Infants will be recruited at Msambweni District Hospital and communities served by Msambweni District Hospital in southern coastal Kenya. In group 1, iron absorption is measured after 3 weeks of MNP consumption containing 5 mg iron in form of NaFeEDTA (2.5 g) and FeFum (2.5 g) but no GOS. In group 2, iron absorption is measured after 3 weeks of MNP consumption containing 5 mg iron in form of NaFeEDTA (2.5 g) and FeFum (2.5 g) and 7.5 g GOS. Iron absorption is measured as the incorporation of stable isotopes into erythrocytes at least 14 days after the test meal administration.
At baseline, a blood sample will be collected from potential study participants for the determination of the following iron and inflammation status parameters: hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), zinc protoporphyrin (ZnPP), C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP). Anthropometrics (height, weight, mid-upper arm and head circumference) will be measured, and demographics, the medical history and the feeding habits will be assessed using a questionnaire. On day 1, infants will be enrolled and randomized into the two groups, and then start the intervention. The infants will consume 1 MNP sachet added to maize porridge per day for a total of 5 weeks. A stool sample will be collected on day 1 for the determination of gut microbiota composition, fecal pH and fecal SCFAs. After 3 weeks of MNP consumption, the two isotopically labelled test meals will be fed to the infants by their caregivers under supervision of the research team on two consecutive mornings between 7 and 8 am. Test meal A will contain 2.5 mg 57Fe in form of FeFum and 2.5 mg iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg of 56Fe and 2 mg of 54Fe). The test meals will consist of maize porridge (5-10% dry weight) and mineral water (30 ml) and will be randomly administered on the two consecutive days (AB or BA). Overnight, only breast milk will be allowed to the infant and no breast milk will be given at least 3 h before test meal administration. Infants will not be allowed to eat or drink for 2 h after the test meal. On the day of the first test meal, a stool sample will be collected and analyzed for gut microbiota composition, fecal pH and fecal SCFAs. Fourteen days after the second test meal administration, 3 ml of whole blood will be collected by venipuncture for iron isotopic analysis and iron and inflammation status. Anthropometrics and the baseline questionnaire will be repeated. Compliance of MNP consumption and adverse event reporting (morbidity monitoring) will be done during weekly visits of the infants.
In a follow-on study, iron absorption from the two above described mentioned iron-fortified maize-based test meals will be measured in 24 infants aged 6-12 months without pre-feeding of GOS. All procedures will be done identical as described above.
- Conditions
- Anemia, Iron-Deficiency
- Being tested
- Fortified maize porridge (MNP+iron), Fortified maize porridge (MNP+iron+GOS)
- Keywords
- Iron fortification, Anemia, Iron Deficiency, Iron Absorption, Prebiotics, Stable isotopes
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified maize porridge (MNP+iron)Dietary supplement
Maize porridge will be home-fortified with the MNP + iron. Maize porridge for the test meal will be fortified with labelled iron compounds
Fortified maize porridge (MNP+iron+GOS)Dietary supplement
Maize porridge will be home-fortified with the MNP + iron + GOS. Maize porridge for the test meal will be fortified with labelled iron compounds
| Study group | Role | What they receive |
|---|---|---|
| MNP+iron and test meal | Active comparator | The MNP contains 400 μg Vitamin A, 5 μgVitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as FeFum and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g)
Iron compound added to the test meal: Test meal A will contain 2.5 mg 57Fe as ferrous fumarate and 2.5 mg of iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg 56Fe and 2 mg 54Fe). Receives: Dietary Supplement: Fortified maize porridge (MNP+iron) |
| MNP+iron+GOS and test meal | Active comparator | The MNP contains 400 μg Vitamin A, 5 μgVitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as ferrous fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g)
Iron compound added to the test meal: Test meal A will contain 2.5 mg 57Fe as ferrous fumarate and 2.5 mg of iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg 56Fe and 2 mg 54Fe). Receives: Dietary Supplement: Fortified maize porridge (MNP+iron+GOS) |
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 5
The change in the isotopic ratio of iron will be measured after the administration of test meals including iron isotopes.
Measured: Baseline and Week 5
Secondary outcomes (4)
Gut microbiome composition
The changes in the gut microbiome composition from baseline to week 3 will be compared among the two groups and correlated to the iron absorption from the test meal.
Measured: Baseline and Week 3
Fecal pH
The changes in fecal pH from baseline to week 3 will be compared among the two groups and correlated to the iron absorption from the test meal.
Measured: Baseline and Week 3
Fecal short chain fatty acids (SCFAs)
The changes in SCFAs from baseline to week 3 will be compared among the two groups and correlated to the iron absorption from the test meal.
Measured: Baseline and Week 3
H.pylori
H.pylori infection as determinant of iron absorption
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia, 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, International Centre for Behavioural Studies, Msambweni District Hospital
- Responsible party
- Sponsor
- Investigators
- Michael Zimmermann, MD, Principal investigator, Swiss Federal Institute of Technology (ETH), Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666417
- Sponsor's protocol ID
- FeGOS_KP
- Acronym
- FeGOS
- Status last verified
- Jul 2018
- First submitted
- 20 Jan 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be published in a peer-review journal.
Publications
Mikulic N, Uyoga MA, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. Consumption of a Single Dose of Prebiotic Galacto-Oligosaccharides Does Not Enhance Iron Absorption from Micronutrient Powders in Kenyan Infants: A Stable Iron Isotope Study. J Nutr. 2021 May 11;151(5):1205-1212. doi: 10.1093/jn/nxab007.
PubMed 33693741Paganini D, Uyoga MA, Cercamondi CI, Moretti D, Mwasi E, Schwab C, Bechtler S, Mutuku FM, Galetti V, Lacroix C, Karanja S, Zimmermann MB. Consumption of galacto-oligosaccharides increases iron absorption from a micronutrient powder containing ferrous fumarate and sodium iron EDTA: a stable-isotope study in Kenyan infants. Am J Clin Nutr. 2017 Oct;106(4):1020-1031. doi: 10.3945/ajcn.116.145060. Epub 2017 Aug 16.
PubMed 28814396
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT02666417
- Acronym / sponsor ID
- FeGOS / FeGOS_KP
- Conditions
- Anemia, Iron-Deficiency
- Keywords
- Iron fortification, Anemia, Iron Deficiency, Iron Absorption, Prebiotics, Stable isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, International Centre for Behavioural Studies, Msambweni District Hospital
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jan 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.
Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. The investigators recently finished a randomized, double blind controlled intervention trial in Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement the intervention study, the present study will compare iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. A stool sample will be collected at baseline and on the first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron absorption from the iron and GOS containing MNP will inform decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still cover the infant requirement for absorbed iron.
Detailed description
Iron absorption from two iron-fortified maize-based test meals will be measured in two groups of 40 infants (total N=80). Infants will be recruited at Msambweni District Hospital and communities served by Msambweni District Hospital in southern coastal Kenya. In group 1, iron absorption is measured after 3 weeks of MNP consumption containing 5 mg iron in form of NaFeEDTA (2.5 g) and FeFum (2.5 g) but no GOS. In group 2, iron absorption is measured after 3 weeks of MNP consumption containing 5 mg iron in form of NaFeEDTA (2.5 g) and FeFum (2.5 g) and 7.5 g GOS. Iron absorption is measured as the incorporation of stable isotopes into erythrocytes at least 14 days after the test meal administration.
At baseline, a blood sample will be collected from potential study participants for the determination of the following iron and inflammation status parameters: hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), zinc protoporphyrin (ZnPP), C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP). Anthropometrics (height, weight, mid-upper arm and head circumference) will be measured, and demographics, the medical history and the feeding habits will be assessed using a questionnaire. On day 1, infants will be enrolled and randomized into the two groups, and then start the intervention. The infants will consume 1 MNP sachet added to maize porridge per day for a total of 5 weeks. A stool sample will be collected on day 1 for the determination of gut microbiota composition, fecal pH and fecal SCFAs. After 3 weeks of MNP consumption, the two isotopically labelled test meals will be fed to the infants by their caregivers under supervision of the research team on two consecutive mornings between 7 and 8 am. Test meal A will contain 2.5 mg 57Fe in form of FeFum and 2.5 mg iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg of 56Fe and 2 mg of 54Fe). The test meals will consist of maize porridge (5-10% dry weight) and mineral water (30 ml) and will be randomly administered on the two consecutive days (AB or BA). Overnight, only breast milk will be allowed to the infant and no breast milk will be given at least 3 h before test meal administration. Infants will not be allowed to eat or drink for 2 h after the test meal. On the day of the first test meal, a stool sample will be collected and analyzed for gut microbiota composition, fecal pH and fecal SCFAs. Fourteen days after the second test meal administration, 3 ml of whole blood will be collected by venipuncture for iron isotopic analysis and iron and inflammation status. Anthropometrics and the baseline questionnaire will be repeated. Compliance of MNP consumption and adverse event reporting (morbidity monitoring) will be done during weekly visits of the infants.
In a follow-on study, iron absorption from the two above described mentioned iron-fortified maize-based test meals will be measured in 24 infants aged 6-12 months without pre-feeding of GOS. All procedures will be done identical as described above.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNP+iron and test meal | Active comparator | Dietary Supplement: Fortified maize porridge (MNP+iron)The MNP contains 400 μg Vitamin A, 5 μgVitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as FeFum and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g) Iron compound added to the test meal: Test meal A will contain 2.5 mg 57Fe as ferrous fumarate and 2.5 mg of iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg 56Fe and 2 mg 54Fe). |
| MNP+iron+GOS and test meal | Active comparator | Dietary Supplement: Fortified maize porridge (MNP+iron+GOS)The MNP contains 400 μg Vitamin A, 5 μgVitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as ferrous fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meal: Test meal A will contain 2.5 mg 57Fe as ferrous fumarate and 2.5 mg of iron as NaFeEDTA (given as 1.5 mg 56Fe and 1 mg 58Fe). Test meal B will contain 5 mg iron in form of FeSO₄ (3 mg 56Fe and 2 mg 54Fe). |
Who may qualify
- Ages
- 6 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age of 6-14 months at baseline
- Assessment of good health as assessed by professional staff at Msambweni District Hospital
- Willingness of their caregiver to provide informed consent
Key exclusion criteria (6 listed)
- Hemoglobin <70 g/L ; these infants will be referred for treatment according to local standard of care.
- Severe underweight (Z-score weight-for-age <-3) and /or severe wasting (Z-score weight-for-height<-3)
- Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- Participants taking part in other studies requiring the drawing of blood
- Participants who are taking iron-containing food supplements or tablets/drops
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 |
|---|---|---|
| Fortified maize porridge (MNP+iron)Maize porridge will be home-fortified with the MNP + iron. Maize porridge for the test meal will be fortified with labelled iron compounds | Dietary supplement | MNP+iron and test meal |
| Fortified maize porridge (MNP+iron+GOS)Maize porridge will be home-fortified with the MNP + iron + GOS. Maize porridge for the test meal will be fortified with labelled iron compounds | Dietary supplement | MNP+iron+GOS and test meal |
Primary outcome
Change from baseline in the isotopic ratio of iron in blood at week 5
Time frame: Baseline and Week 5
The change in the isotopic ratio of iron will be measured after the administration of test meals including iron isotopes.
4 secondary outcomes
Gut microbiome composition
Time frame: Baseline and Week 3
Fecal pH
Time frame: Baseline and Week 3
Fecal short chain fatty acids (SCFAs)
Time frame: Baseline and Week 3
H.pylori
Time frame: Baseline
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 19 Jul 2018.
- Derived from this study: PubMed 33693741Mikulic N, Uyoga MA, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. Consumption of a Single Dose of Prebiotic Galacto-Oligosaccharides Does Not Enhance Iron Absorption from Micronutrient Powders in Kenyan Infants: A Stable Iron Isotope Study. J Nutr. 2021 May 11;151(5):1205-1212. doi: 10.1093/jn/nxab007.
- Derived from this study: PubMed 28814396Paganini D, Uyoga MA, Cercamondi CI, Moretti D, Mwasi E, Schwab C, Bechtler S, Mutuku FM, Galetti V, Lacroix C, Karanja S, Zimmermann MB. Consumption of galacto-oligosaccharides increases iron absorption from a micronutrient powder containing ferrous fumarate and sodium iron EDTA: a stable-isotope study in Kenyan infants. Am J Clin Nutr. 2017 Oct;106(4):1020-1031. doi: 10.3945/ajcn.116.145060. Epub 2017 Aug 16.
- Individual participant dataSharing planned: Yes. Data will be published in a peer-review journal.
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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.
Michael Zimmermann, MD principal investigator
Swiss Federal Institute of Technology (ETH), Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified maize porridge (MNP+iron) and Fortified maize porridge (MNP+iron+GOS) in people with Anemia, Iron-Deficiency, run by Swiss Federal Institute of Technology at 1 site in Kenya.
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 3 inclusion and 6 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 19 Jul 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 Kenya. 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 5 (time frame: Baseline and Week 5). 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 NCT02666417, which also lists 2 linked publications.
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 19 Jul 2018.