AnemiaNCT02989311
Effect of Timing of Micronutrient Powder Consumption on Iron Absorption in Infants
A study testing Fortified maize porridge (MNP and Iron) and Fortified Maize porridge (MNP + Iron + GOS) in people with Anemia and 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 by ensuring that the iron needs of infants and… 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 and Iron) and Fortified Maize porridge (MNP + Iron + GOS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteKenya
- Study dates
- Aug 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 health professional staff at Msambweni County Referral 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
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 by ensuring that the iron needs of infants and young children are met without changing their traditional diet. In order to optimize iron absorption timing of MNP consumption might as well be important. This is because hepcidin, a key regulator of systemic iron balance, shows a circadian increase that may influence morning versus afternoon iron absorption from the MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit iron absorption from a second dose, consumed close in time to the first dose.
To determine the difference between i) morning versus afternoon iron absorption and ii) consecutive versus alternate day iron absorption, investigators will enrol 20 infants from Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days and 1 alternate day. In both studies, fourteen days after the last 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. Hepcidin concentrations will be measured before the morning and afternoon meals (study 1) and after second consecutive meal (study 2).
Knowing the effect of time on the expected iron absorption will inform decisions on the ideal timing of MNP to cover the infant's requirement for absorbed iron.
Read the detailed description
20 infants will be recruited from the Msambweni County Referral Hospital in southern coastal Kenya to participate in both studies.
Study 1:
At baseline a morning blood sample will be collected from potential study participants for the determination of the following iron and inflammation status parameters: hemoglobin (Hb), hepcidin, 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.
Infants will consume the 1st test meal the next day after enrolment in the morning (day1). On day 2 a 2nd blood sample (1ml) will be collected in the afternoon quantify afternoon concentration of hepcidin in plasma and then the infants will consume the 2nd meal on the 3rd day in the afternoon.
The two isotopically labelled test meals will be fed to the infants by their caregivers under supervision of the research team. The morning test meal A will contain 12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. The afternoon test meal will contain 12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10 mg of 56Fe.
The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml) and will be randomly administered on the two alternate days (AB or BA). Overnight, only breast milk will be allowed to the infant before coming for the morning meal and no breast milk will be given at least 3 h before both morning and afternoon test meal administration. Infants will not be allowed to eat or drink for 2 h after the test meal. 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 health status will be assessed.
Study 2:
At baseline a blood sample will be collected from potential study participants for the determination of iron and inflammation status parameters: hemoglobin (Hb), hepcidin, 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.
Infants will be randomized to consume the consecutive days or alternate day meal schedule on day 1. 1ml of blood will be collected after the second consecutive meal to determine hepcidin level.
Test meal A will contain 12 mg of iron as ferrous sulfate given as 2 mg of 54Fe and 10mg of 56Fe. Test meal B will contain 12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. Test meal C will contain 12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe. All test meals will be consumed in the morning.
The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml). 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. Test meals plus mineral water will be consumed completely in the presence of the investigators, and the infant will not be allowed to eat or drink for 2 h after the test meal. Fourteen days after the third test meal, 3 ml of whole blood will be collected by venipuncture for iron and inflammation status, and iron analysis in red blood cells.
- Conditions
- Anemia, Iron Deficiency
- Being tested
- Fortified maize porridge (MNP and Iron), Fortified Maize porridge (MNP + Iron + GOS)
- Keywords
- Iron absorption, Iron deficiency, Hepcidin, Stable isotopes, Anemia, Infants
- Medical subject headings
- 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 and Iron)Dietary supplement
Maize porridge fortified with MNP and labelled iron compound
Fortified Maize porridge (MNP + Iron + GOS)Dietary supplement
Maize porridge fortified with MNP + GOS and labelled iron compound
| Study group | Role | What they receive |
|---|---|---|
| Study 1:Morning test meal+Iron+MNP | Active comparator | The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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, maltodextrin carrier (added up to 11g). Iron compound added to the morning test meal A:12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron) Receives: Dietary Supplement: Fortified maize porridge (MNP and Iron) |
| Study 1:Afternoon test meal+Iron+MNP | Active comparator | The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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, maltodextrin carrier (added up to 11g). Iron compound added to the afternoon test meal B:12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron) Receives: Dietary Supplement: Fortified maize porridge (MNP and Iron) |
| Study 2: Consecutive meals+Iron+MNP+GOS | Active comparator | The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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 meals:Test meal A will contain 12mg of ferrous sulphate given as 2mg 54Fe and 10mg 56Fe. Test meal B will contain 12mg of ferrous sulphate given as 2mg 57Fe and 10mg 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS) Receives: Dietary Supplement: Fortified Maize porridge (MNP + Iron + GOS) |
| Study 2:Alternate meal+Iron+MNP+GOS | Active comparator | The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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 C: 12mg of ferrous sulphate given as 2mg 58Fe and 10mg.
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS) 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 isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively
Measured: Baseline and day 18, baseline and day 19
Secondary outcomes (3)
Hepcidin concentration
We will measure hepcidin concentration in the morning and in the afternoon and then after consumption of a 2nd consecutive test meal in Study 1 and 2 respectively
Measured: Baseline and day 3, and day 2 for study 1 and 2 respectively
Iron status
We will assess haemoglobin, plasma ferritin and soluble transferrin receptor to define the iron status.
Measured: Baseline and days 18 and 19 for study 1 and 2 respectively
Inflammation status
We will assess C-reactive protein and alpha acid glycoprotein to assess systemic inflammatory status
Measured: Baseline and days 18 and 19 for study 1 and 2 respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 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, Msambweni County Referral Hospital
- Responsible party
- Sponsor
- Investigators
- Michael Zimmermann, MD, Principal investigator, Swiss Federal Institute of Technology (ETH), Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989311
- Sponsor's protocol ID
- FeGOS_Hepcidin
- Status last verified
- Dec 2016
- First submitted
- 18 Oct 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be published in a peer-review journal
Publications
Uyoga MA, Mikulic N, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. Am J Clin Nutr. 2020 Oct 1;112(4):1132-1141. doi: 10.1093/ajcn/nqaa174.
PubMed 32678434
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. 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
- NCT02989311
- Acronym / sponsor ID
- FeGOS_Hepcidin
- Conditions
- Anemia, Iron Deficiency
- Keywords
- Iron absorption, Iron deficiency, Hepcidin, Stable isotopes, Anemia, Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, Msambweni County Referral Hospital
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Dec 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 by ensuring that the iron needs of infants and young children are met without changing their traditional diet. In order to optimize iron absorption timing of MNP consumption might as well be important. This is because hepcidin, a key regulator of systemic iron balance, shows a circadian increase that may influence morning versus afternoon iron absorption from the MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit iron absorption from a second dose, consumed close in time to the first dose.
To determine the difference between i) morning versus afternoon iron absorption and ii) consecutive versus alternate day iron absorption, investigators will enrol 20 infants from Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days and 1 alternate day. In both studies, fourteen days after the last 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. Hepcidin concentrations will be measured before the morning and afternoon meals (study 1) and after second consecutive meal (study 2).
Knowing the effect of time on the expected iron absorption will inform decisions on the ideal timing of MNP to cover the infant's requirement for absorbed iron.
Detailed description
20 infants will be recruited from the Msambweni County Referral Hospital in southern coastal Kenya to participate in both studies.
Study 1:
At baseline a morning blood sample will be collected from potential study participants for the determination of the following iron and inflammation status parameters: hemoglobin (Hb), hepcidin, 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.
Infants will consume the 1st test meal the next day after enrolment in the morning (day1). On day 2 a 2nd blood sample (1ml) will be collected in the afternoon quantify afternoon concentration of hepcidin in plasma and then the infants will consume the 2nd meal on the 3rd day in the afternoon.
The two isotopically labelled test meals will be fed to the infants by their caregivers under supervision of the research team. The morning test meal A will contain 12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. The afternoon test meal will contain 12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10 mg of 56Fe.
The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml) and will be randomly administered on the two alternate days (AB or BA). Overnight, only breast milk will be allowed to the infant before coming for the morning meal and no breast milk will be given at least 3 h before both morning and afternoon test meal administration. Infants will not be allowed to eat or drink for 2 h after the test meal. 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 health status will be assessed.
Study 2:
At baseline a blood sample will be collected from potential study participants for the determination of iron and inflammation status parameters: hemoglobin (Hb), hepcidin, 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.
Infants will be randomized to consume the consecutive days or alternate day meal schedule on day 1. 1ml of blood will be collected after the second consecutive meal to determine hepcidin level.
Test meal A will contain 12 mg of iron as ferrous sulfate given as 2 mg of 54Fe and 10mg of 56Fe. Test meal B will contain 12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. Test meal C will contain 12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe. All test meals will be consumed in the morning.
The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml). 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. Test meals plus mineral water will be consumed completely in the presence of the investigators, and the infant will not be allowed to eat or drink for 2 h after the test meal. Fourteen days after the third test meal, 3 ml of whole blood will be collected by venipuncture for iron and inflammation status, and iron analysis in red blood cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study 1:Morning test meal+Iron+MNP | Active comparator | Dietary Supplement: Fortified maize porridge (MNP and Iron)The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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, maltodextrin carrier (added up to 11g). Iron compound added to the morning test meal A:12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron) |
| Study 1:Afternoon test meal+Iron+MNP | Active comparator | Dietary Supplement: Fortified maize porridge (MNP and Iron)The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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, maltodextrin carrier (added up to 11g). Iron compound added to the afternoon test meal B:12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe. Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron) |
| Study 2: Consecutive meals+Iron+MNP+GOS | Active comparator | Dietary Supplement: Fortified Maize porridge (MNP + Iron + GOS)The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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 meals:Test meal A will contain 12mg of ferrous sulphate given as 2mg 54Fe and 10mg 56Fe. Test meal B will contain 12mg of ferrous sulphate given as 2mg 57Fe and 10mg 56Fe. Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS) |
| Study 2:Alternate meal+Iron+MNP+GOS | Active comparator | Dietary Supplement: Fortified Maize porridge (MNP + Iron + GOS)The MNP contains 400 μg Vitamin A, 5 μg Vitamin 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 C: 12mg of ferrous sulphate given as 2mg 58Fe and 10mg. Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS) |
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 health professional staff at Msambweni County Referral Hospital
- Willingness of their caregiver to provide informed consent
Key exclusion criteria (5 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 and Iron)Maize porridge fortified with MNP and labelled iron compound | Dietary supplement | Study 1:Afternoon test meal+Iron+MNP, Study 1:Morning test meal+Iron+MNP |
| Fortified Maize porridge (MNP + Iron + GOS)Maize porridge fortified with MNP + GOS and labelled iron compound | Dietary supplement | Study 2: Consecutive meals+Iron+MNP+GOS, Study 2:Alternate meal+Iron+MNP+GOS |
Primary outcome
Change from baseline in isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively
Time frame: Baseline and day 18, baseline and day 19
3 secondary outcomes
Hepcidin concentration
Time frame: Baseline and day 3, and day 2 for study 1 and 2 respectively
Iron status
Time frame: Baseline and days 18 and 19 for study 1 and 2 respectively
Inflammation status
Time frame: Baseline and days 18 and 19 for study 1 and 2 respectively
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 6 Oct 2017.
- Derived from this study: PubMed 32678434Uyoga MA, Mikulic N, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. Am J Clin Nutr. 2020 Oct 1;112(4):1132-1141. doi: 10.1093/ajcn/nqaa174.
- 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 and Iron) and Fortified Maize porridge (MNP + Iron + GOS) in people with Anemia and 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 5 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 6 Oct 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 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 isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively (time frame: Baseline and day 18, baseline and day 19). 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 NCT02989311, 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 6 Oct 2017.