Anemia, Iron-deficiencyFeHMOGOSNCT04163406
The Effect of Human Milk Oligosaccharides and Galacto-oligosaccharides on Iron Absorption in Kenyan Infants
A study testing ferrous fumarate, ferrous fumarate + GOS and ferrous fumarate + HMOs in people with Anemia, Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Kenya.
Trial summary
Effective and safe strategies to deliver iron to infants and young children in Sub-Saharan Africa are urgently needed. One potential strategy to improve safety of iron fortification is to limit the total amount of unabsorbed iron entering the colon by lowering the daily iron dose but at the same time ensure efficacy… Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-deficiency
- What is being tested?
- ferrous fumarate, ferrous fumarate + GOS and ferrous fumarate + HMOs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteKenya
- Study dates
- 21 Nov 2019to 9 Nov 2020
- 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 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of 8-12 months at baseline
- Assessment of good health as assessed by professional staff at Msambweni District Hospital
- The caregiver is willing to participate in the study
- The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)
- Residence in the study area for the period of the study
- Willingness of the caregiver to provide 2 blood samples from their child and 1 breast milk sample from the mother
Who cannot join
- Hb <70 g/L
- 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
- Regular intake (>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Human Milk Oligosaccharides (HMOs) (2'-Fucosyllactose (2'-FL) and Lacto-N-neotetraose (LNnT)) and Galacto-oligosaccharides (GOS) on Iron Absorption From a Maize-based Porridge in Kenyan Infants
Effective and safe strategies to deliver iron to infants and young children in Sub-Saharan Africa are urgently needed. One potential strategy to improve safety of iron fortification is to limit the total amount of unabsorbed iron entering the colon by lowering the daily iron dose but at the same time ensure efficacy by maximizing absorption from this lower dose. In Kenyan infants, the investigators have recently shown that consumption of 7.5 g of the prebiotic galacto-oligosaccharides (GOS) compared to no GOS consumption increased iron absorption from an iron containing micronutrient powder by ≈60%. It is uncertain whether a lower dose of GOS can also enhance iron absorption. Another question is whether HMOs, 'natural prebiotics' found in high concentration in human breast milk, can also increase iron absorption similar to GOS. Therefore, the aim of this study is to measure fractional iron absorption from a maize-based porridge fortified with A) iron as ferrous fumarate, B) iron as ferrous fumarate and GOS and C) iron ferrous fumarate and HMOs, using an established stable iron isotope technique in 55 infants aged 8-12 months living in Msambweni and surrounding rural communities, Kwale County of southern coastal Kenya. Assessing the effect of a low dose of GOS and of HMOs on iron absorption will provide valuable information towards the development of new, highly bioavailable iron formulations for African infants.
As per the local standard of care, the participants who will be iron-deficient anemic at the end of the study will be treated with oral iron supplements. To evaluate the effects of iron supplementation on iron and anemia status and to estimate obligatory iron losses in the gastrointestinal tract, blood and fecal samples will be collected before, during and fourteen days after the beginning of the treatment with oral iron supplements. Data about the efficacy of current supplementation strategies in iron-deficient anemic children and obligatory iron losses would provide additional evidence for the optimization of iron supplementation regimens.
Read the detailed description
Iron absorption from differently labelled iron-fortified maize-based test meals will be measured in 55 infants. At baseline a venipuncture blood sample will be collected from all infants for the determination of the following iron and inflammation status parameters: hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protein (CRP) and alpha-1-acid glycoprotein (AGP), and anti-oligosaccharide immunoglobulins. Anthropometrics will be measured; demographics, the medical history and the feeding habits will be assessed using a questionnaire. A breast milk sample from all mothers will be collected for determination of HMO profile and maternal secretor status. After baseline, 30 infants will consume three different test meals on alternate days (day 1, day 3, and day 5) and 25 infants will consume two different test meals on alternate test meal days (day 1, day 3 and day 5). The order of consumption of the three test meals will be randomly assigned. Test meal A will contain 5 mg of iron as ferrous fumarate given as 2.5 mg Fe-56 and 2.5 mg Fe-54 (control test meal). Test meal B will contain 5 mg of iron as ferrous fumarate given as 2.5 mg Fe-56 and 2.5 mg Fe-58 and 4 g of GOS-75 (≈ 3 g GOS) (GOS test meal).Test meal C will contain 5 mg of iron as ferrous fumarate given as 2.5 mg Fe-56 and 2.5 mg Fe-57 and 2.0 g 2'-fucosyllactose (2'-FL) and 1.0 g lacto-N-neotetraose (LNnT) (HMO test meal). The test meals will be based on maize porridge, consisting of refined maize flour, sugar and mineral water, and will be administered between 0700 and 0900. Overnight, only breast milk will be allowed to the infant and no breast milk and no other food 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 administration (day 17 and 19, respectively) a whole blood sample will be collected by venipuncture for analysis of the ratios of the different molecular weight iron incorporation into red blood cells and determination of iron and inflammation status (Hb, PF, sTfR, CRP and AGP). Furthermore, anthropometrics and some parts of the baseline questionnaire will be repeated.
At endpoint (day 17 and 19, respectively), if the infant will be diagnosed with iron-deficiency anemia (Hb concentration below 110 g/l and low red blood cells mean corpuscular volume), the caregiver will be instructed to give the infant 4mg/kg iron in the form of oral syrup, daily. Compliance during the follow-up will be assessed by weighting the iron syrup containers before and after 14 days of treatment with the iron syrup. Collection of fecal samples will be performed over 3 time periods of 72h each. The first time period will start the 3 days prior of beginning of oral iron supplementation, the second will take place on day 4, 5 and 6 of oral iron supplementation and the last on day 15, 16 and 17 of oral iron supplementation. A venepuncture blood sample will be collected in the morning after the last day of fecal sample collection (day 18 of oral iron supplementation). Furthermore, some parts of the baseline questionnaire will be repeated. Adverse events (AEs) will be assessed throughout the entire study period.
- Conditions
- Anemia, Iron-deficiency
- Being tested
- ferrous fumarate, ferrous fumarate + GOS, ferrous fumarate + HMOs
- Keywords
- Anemia, Iron-deficiency, Iron absorption, Prebiotic, Galacto-oligosaccharides, Human milk oligosaccharides, Infants, Kenya
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous fumarateDietary supplement
Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate
ferrous fumarate + GOSDietary supplement
Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate and GOS (3g)
ferrous fumarate + HMOsDietary supplement
Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate and HMOs (2'-FL (2g) + LNnT(1g))
| Study group | Role | What they receive |
|---|---|---|
| ferrous fumarate | Active comparator | Maize-based porridge fortified with iron (5mg) as ferrous fumarate Receives: Dietary Supplement: ferrous fumarate |
| ferrous fumarate + GOS | Active comparator | Maize-based porridge fortified with iron (5mg) as ferrous fumarate + GOS (3g) Receives: Dietary Supplement: ferrous fumarate + GOS |
| ferrous fumarate + HMOs | Active comparator | Maize-based porridge fortified with iron (5mg) as ferrous fumarate + HMOs (2'-FL (2g) + LNnT (1g)) Receives: Dietary Supplement: ferrous fumarate + HMOs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption in %
Fractional iron absorption (%), measured as erythrocyte incorporation of stable iron isotopes at day 19
Measured: Day 19
Secondary outcomes (26)
Hemoglobin (Hb)
Iron status will be determined at baseline
Measured: Baseline
Hemoglobin (Hb)
Iron status will be determined at day 19
Measured: Day 19
Plasma Ferritin (PF)
Iron status will be determined at baseline
Measured: Baseline
Plasma Ferritin (PF)
Iron status will be determined at day 19
Measured: Day 19
Soluble Transferrin Receptor (sTfR)
Iron status will be determined at baseline
Measured: Baseline
Soluble Transferrin Receptor (sTfR)
Iron status will be determined at day 19
Measured: Day 19
C-reactive protein (CRP)
Inflammation status will be determined at baseline
Measured: Baseline
C-reactive protein (CRP)
Inflammation status will be determined at day 19
Measured: Day 19
Alpha-1-acid glycoprotein (AGP)
Inflammation status will be determined at baseline
Measured: Baseline
Alpha-1-acid glycoprotein (AGP)
Inflammation status will be determined at day 19
Measured: Day 19
Human Milk Oligosaccharides concentrations in breast milk
Human Milk Oligosaccharides concentrations in breast milk of the mothers of the participating infants will be measured at baseline to determine maternal secretor status.
Measured: Baseline
Human Milk Oligosaccharides concentrations in breast milk
Human Milk Oligosaccharides concentrations in the breast milk of the mothers of the participating infants will be measured at Day 19 to determine maternal secretor status.
Measured: Day 19
Anti-oligosaccharide immunoglobulins
Infant blood serum immunoglobulins toward mucosal oligosaccharide antigens and microbial carbohydrate antigens will be measured at baseline
Measured: Baseline
Intestinal Fatty Acid Binding Protein (I-FABP) in infants diagnosed with iron deficiency anemia
I-FABP will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care.
Measured: Day 19
Fecal calprotectin in infants diagnosed with iron deficiency anemia
Fecal calprotectin will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care. Fecal calprotectin will be measured 3 days before beginning of oral iron supplementation. The sampling period will last for 72 hours.
Measured: 3 days before oral iron supplementation
Fecal calprotectin in infants diagnosed with iron deficiency anemia
Fecal calprotectin will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care. Fecal calprotectin will be measured on day 4 of oral iron supplementation. The sampling period will last for 72 hours.
Measured: Day 4 of oral iron supplementation
Fecal calprotectin in infants diagnosed with iron deficiency anemia
Fecal calprotectin will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care. Fecal calprotectin will be measured on day 15 of oral iron supplementation. The sampling period will last for 72 hours.
Measured: Day 15 of oral iron supplementation
Hemoglobin (Hb) in infants diagnosed with iron deficiency anemia
Iron status will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care
Measured: Day 18 of oral iron supplementation
Plasma Ferritin (PF) in infants diagnosed with iron deficiency anemia
Iron status will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care
Measured: Day 18 of oral iron supplementation
Soluble Transferrin Receptor (sTfR) in infants diagnosed with iron deficiency anemia
Iron status will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care
Measured: Day 18 of oral iron supplementation
C-reactive protein (CRP) in infants diagnosed with iron deficiency anemia
Inflammation status will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care
Measured: Day 18 of oral iron supplementation
Alpha-1-acid glycoprotein (AGP) in infants diagnosed with iron deficiency anemia
Inflammation status will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care
Measured: Day 18 of oral iron supplementation
Hemoglobin in stool from infants diagnosed with iron deficiency anemia
Hemoglobin concentration will be assessed in stools from infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care. Hemoglobin concentration in stools will be measured 3 days before beginning of oral iron supplementation. The sampling period will last for 72 hours.
Measured: 3 days before oral iron supplementation
Hemoglobin in stool from infants diagnosed with iron deficiency anemia
Hemoglobin concentration will be assessed in stools from infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care. Hemoglobin concentration in stools will be measured on day 4 of oral iron supplementation. The sampling period will last for 72 hours.
Measured: Day 4 of oral iron supplementation
Hemoglobin in stool from infants diagnosed with iron deficiency anemia
Hemoglobin concentration will be assessed in stools from infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care. Hemoglobin concentration in stools will be measured on day 15 of oral iron supplementation. The sampling period will last for 72 hours.
Measured: Day 15 of oral iron supplementation.
Intestinal Fatty Acid Binding Protein (I-FABP) in infants diagnosed with iron deficiency anemia
I-FABP will be assessed in infants diagnosed with iron-deficiency anaemia and receiving supplementation with oral iron syrup as per local standard of care.
Measured: Day 18 of oral iron supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start21 Nov 2019
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Jomo Kenyatta University of Agriculture and Technology, University Children's Hospital, Zurich
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, Prof. Dr., Principal investigator, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163406
- Sponsor's protocol ID
- FeHMOGOS
- Acronym
- FeHMOGOS
- Status last verified
- Jun 2022
- First submitted
- 29 Oct 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paganini 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 28814396Giorgetti A, Paganini D, Nyilima S, Kottler R, Frick M, Karanja S, Hennet T, Zimmermann MB. The effects of 2'-fucosyllactose and lacto-N-neotetraose, galacto-oligosaccharides, and maternal human milk oligosaccharide profile on iron absorption in Kenyan infants. Am J Clin Nutr. 2023 Jan;117(1):64-72. doi: 10.1016/j.ajcnut.2022.10.005. Epub 2022 Dec 15.
PubMed 36789945
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Milk Oligosaccharides (HMOs) (2'-Fucosyllactose (2'-FL) and Lacto-N-neotetraose (LNnT)) and Galacto-oligosaccharides (GOS) on Iron Absorption From a Maize-based Porridge in Kenyan Infants
- ClinicalTrials.gov ID
- NCT04163406
- Acronym / sponsor ID
- FeHMOGOS / FeHMOGOS
- Conditions
- Anemia, Iron-deficiency
- Keywords
- Anemia, Iron-deficiency, Iron absorption, Prebiotic, Galacto-oligosaccharides, Human milk oligosaccharides, Infants, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Zurich, Jomo Kenyatta University of Agriculture and Technology, University Children's Hospital, Zurich
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 14 Nov 2019 (actual)
- 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.
Effective and safe strategies to deliver iron to infants and young children in Sub-Saharan Africa are urgently needed. One potential strategy to improve safety of iron fortification is to limit the total amount of unabsorbed iron entering the colon by lowering the daily iron dose but at the same time ensure efficacy by maximizing absorption from this lower dose. In Kenyan infants, the investigators have recently shown that consumption of 7.5 g of the prebiotic galacto-oligosaccharides (GOS) compared to no GOS consumption increased iron absorption from an iron containing micronutrient powder by ≈60%. It is uncertain whether a lower dose of GOS can also enhance iron absorption. Another question is whether HMOs, 'natural prebiotics' found in high concentration in human breast milk, can also increase iron absorption similar to GOS. Therefore, the aim of this study is to measure fractional iron absorption from a maize-based porridge fortified with A) iron as ferrous fumarate, B) iron as ferrous fumarate and GOS and C) iron ferrous fumarate and HMOs, using an established stable iron isotope technique in 55 infants aged 8-12 months living in Msambweni and surrounding rural communities, Kwale County of southern coastal Kenya. Assessing the effect of a low dose of GOS and of HMOs on iron absorption will provide valuable information towards the development of new, highly bioavailable iron formulations for African infants.
As per the local standard of care, the participants who will be iron-deficient anemic at the end of the study will be treated with oral iron supplements. To evaluate the effects of iron supplementation on iron and anemia status and to estimate obligatory iron losses in the gastrointestinal tract, blood and fecal samples will be collected before, during and fourteen days after the beginning of the treatment with oral iron supplements. Data about the efficacy of current supplementation strategies in iron-deficient anemic children and obligatory iron losses would provide additional evidence for the optimization of iron supplementation regimens.
Detailed description
Iron absorption from differently labelled iron-fortified maize-based test meals will be measured in 55 infants. At baseline a venipuncture blood sample will be collected from all infants for the determination of the following iron and inflammation status parameters: hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protein (CRP) and alpha-1-acid glycoprotein (AGP), and anti-oligosaccharide immunoglobulins. Anthropometrics will be measured; demographics, the medical history and the feeding habits will be assessed using a questionnaire. A breast milk sample from all mothers will be collected for determination of HMO profile and maternal secretor status. After baseline, 30 infants will consume three different test meals on alternate days (day 1, day 3, and day 5) and 25 infants will consume two different test meals on alternate test meal days (day 1, day 3 and day 5). The order of consumption of the three test meals will be randomly assigned. Test meal A will contain 5 mg of iron as ferrous fumarate given as 2.5 mg Fe-56 and 2.5 mg Fe-54 (control test meal). Test meal B will contain 5 mg of iron as ferrous fumarate given as 2.5 mg Fe-56 and 2.5 mg Fe-58 and 4 g of GOS-75 (≈ 3 g GOS) (GOS test meal).Test meal C will contain 5 mg of iron as ferrous fumarate given as 2.5 mg Fe-56 and 2.5 mg Fe-57 and 2.0 g 2'-fucosyllactose (2'-FL) and 1.0 g lacto-N-neotetraose (LNnT) (HMO test meal). The test meals will be based on maize porridge, consisting of refined maize flour, sugar and mineral water, and will be administered between 0700 and 0900. Overnight, only breast milk will be allowed to the infant and no breast milk and no other food 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 administration (day 17 and 19, respectively) a whole blood sample will be collected by venipuncture for analysis of the ratios of the different molecular weight iron incorporation into red blood cells and determination of iron and inflammation status (Hb, PF, sTfR, CRP and AGP). Furthermore, anthropometrics and some parts of the baseline questionnaire will be repeated.
At endpoint (day 17 and 19, respectively), if the infant will be diagnosed with iron-deficiency anemia (Hb concentration below 110 g/l and low red blood cells mean corpuscular volume), the caregiver will be instructed to give the infant 4mg/kg iron in the form of oral syrup, daily. Compliance during the follow-up will be assessed by weighting the iron syrup containers before and after 14 days of treatment with the iron syrup. Collection of fecal samples will be performed over 3 time periods of 72h each. The first time period will start the 3 days prior of beginning of oral iron supplementation, the second will take place on day 4, 5 and 6 of oral iron supplementation and the last on day 15, 16 and 17 of oral iron supplementation. A venepuncture blood sample will be collected in the morning after the last day of fecal sample collection (day 18 of oral iron supplementation). Furthermore, some parts of the baseline questionnaire will be repeated. Adverse events (AEs) will be assessed throughout the entire study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ferrous fumarate | Active comparator | Dietary Supplement: ferrous fumarateMaize-based porridge fortified with iron (5mg) as ferrous fumarate |
| ferrous fumarate + GOS | Active comparator | Dietary Supplement: ferrous fumarate + GOSMaize-based porridge fortified with iron (5mg) as ferrous fumarate + GOS (3g) |
| ferrous fumarate + HMOs | Active comparator | Dietary Supplement: ferrous fumarate + HMOsMaize-based porridge fortified with iron (5mg) as ferrous fumarate + HMOs (2'-FL (2g) + LNnT (1g)) |
Who may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age of 8-12 months at baseline
- Assessment of good health as assessed by professional staff at Msambweni District Hospital
- The caregiver is willing to participate in the study
- The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)
- Residence in the study area for the period of the study
Key exclusion criteria (5 listed)
- Hb <70 g/L
- 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
- Regular intake (>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months
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 fumarateMaize-based porridge fortified with iron (5mg) in form of ferrous fumarate | Dietary supplement | ferrous fumarate |
| ferrous fumarate + GOSMaize-based porridge fortified with iron (5mg) in form of ferrous fumarate and GOS (3g) | Dietary supplement | ferrous fumarate + GOS |
| ferrous fumarate + HMOsMaize-based porridge fortified with iron (5mg) in form of ferrous fumarate and HMOs (2'-FL (2g) + LNnT(1g)) | Dietary supplement | ferrous fumarate + HMOs |
Primary outcome
Fractional iron absorption in %
Time frame: Day 19
Fractional iron absorption (%), measured as erythrocyte incorporation of stable iron isotopes at day 19
26 secondary outcomes
Hemoglobin (Hb)
Time frame: Baseline
Hemoglobin (Hb)
Time frame: Day 19
Plasma Ferritin (PF)
Time frame: Baseline
Plasma Ferritin (PF)
Time frame: Day 19
Soluble Transferrin Receptor (sTfR)
Time frame: Baseline
Soluble Transferrin Receptor (sTfR)
Time frame: Day 19
C-reactive protein (CRP)
Time frame: Baseline
C-reactive protein (CRP)
Time frame: Day 19
Alpha-1-acid glycoprotein (AGP)
Time frame: Baseline
Alpha-1-acid glycoprotein (AGP)
Time frame: Day 19
Human Milk Oligosaccharides concentrations in breast milk
Time frame: Baseline
Human Milk Oligosaccharides concentrations in breast milk
Time frame: Day 19
Anti-oligosaccharide immunoglobulins
Time frame: Baseline
Intestinal Fatty Acid Binding Protein (I-FABP) in infants diagnosed with iron deficiency anemia
Time frame: Day 19
Fecal calprotectin in infants diagnosed with iron deficiency anemia
Time frame: 3 days before oral iron supplementation
Fecal calprotectin in infants diagnosed with iron deficiency anemia
Time frame: Day 4 of oral iron supplementation
Fecal calprotectin in infants diagnosed with iron deficiency anemia
Time frame: Day 15 of oral iron supplementation
Hemoglobin (Hb) in infants diagnosed with iron deficiency anemia
Time frame: Day 18 of oral iron supplementation
Plasma Ferritin (PF) in infants diagnosed with iron deficiency anemia
Time frame: Day 18 of oral iron supplementation
Soluble Transferrin Receptor (sTfR) in infants diagnosed with iron deficiency anemia
Time frame: Day 18 of oral iron supplementation
C-reactive protein (CRP) in infants diagnosed with iron deficiency anemia
Time frame: Day 18 of oral iron supplementation
Alpha-1-acid glycoprotein (AGP) in infants diagnosed with iron deficiency anemia
Time frame: Day 18 of oral iron supplementation
Hemoglobin in stool from infants diagnosed with iron deficiency anemia
Time frame: 3 days before oral iron supplementation
Hemoglobin in stool from infants diagnosed with iron deficiency anemia
Time frame: Day 4 of oral iron supplementation
Hemoglobin in stool from infants diagnosed with iron deficiency anemia
Time frame: Day 15 of oral iron supplementation.
Intestinal Fatty Acid Binding Protein (I-FABP) in infants diagnosed with iron deficiency anemia
Time frame: Day 18 of oral iron supplementation
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 23 Jun 2022.
- Background: 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.
- Derived from this study: PubMed 36789945Giorgetti A, Paganini D, Nyilima S, Kottler R, Frick M, Karanja S, Hennet T, Zimmermann MB. The effects of 2'-fucosyllactose and lacto-N-neotetraose, galacto-oligosaccharides, and maternal human milk oligosaccharide profile on iron absorption in Kenyan infants. Am J Clin Nutr. 2023 Jan;117(1):64-72. doi: 10.1016/j.ajcnut.2022.10.005. Epub 2022 Dec 15.
- Individual participant dataSharing planned: No
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Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
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 B Zimmermann, Prof. Dr. principal investigator
Swiss Federal Institute of Technology
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 fumarate, ferrous fumarate + GOS and ferrous fumarate + HMOs 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 6 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 23 Jun 2022. 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?
Fractional iron absorption in % (time frame: 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 NCT04163406, 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 23 Jun 2022.