Anemia, Iron-deficiency Clinical Trial
— FeHMOGOSOfficial 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
Verified date | June 2022 |
Source | Swiss Federal Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | November 9, 2020 |
Est. primary completion date | November 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Months to 12 Months |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Msambweni County Referral Hospital | Msambweni | Kwale |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology | Jomo Kenyatta University of Agriculture and Technology, University Children's Hospital, Zurich, University of Zurich |
Kenya,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractional iron absorption in % | Fractional iron absorption (%), measured as erythrocyte incorporation of stable iron isotopes at day 19 | Day 19 | |
Secondary | Hemoglobin (Hb) | Iron status will be determined at baseline | Baseline | |
Secondary | Hemoglobin (Hb) | Iron status will be determined at day 19 | Day 19 | |
Secondary | Plasma Ferritin (PF) | Iron status will be determined at baseline | Baseline | |
Secondary | Plasma Ferritin (PF) | Iron status will be determined at day 19 | Day 19 | |
Secondary | Soluble Transferrin Receptor (sTfR) | Iron status will be determined at baseline | Baseline | |
Secondary | Soluble Transferrin Receptor (sTfR) | Iron status will be determined at day 19 | Day 19 | |
Secondary | C-reactive protein (CRP) | Inflammation status will be determined at baseline | Baseline | |
Secondary | C-reactive protein (CRP) | Inflammation status will be determined at day 19 | Day 19 | |
Secondary | Alpha-1-acid glycoprotein (AGP) | Inflammation status will be determined at baseline | Baseline | |
Secondary | Alpha-1-acid glycoprotein (AGP) | Inflammation status will be determined at day 19 | Day 19 | |
Secondary | 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. | Baseline | |
Secondary | 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. | Day 19 | |
Secondary | Anti-oligosaccharide immunoglobulins | Infant blood serum immunoglobulins toward mucosal oligosaccharide antigens and microbial carbohydrate antigens will be measured at baseline | Baseline | |
Secondary | 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. | Day 19 | |
Secondary | 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. | 3 days before oral iron supplementation | |
Secondary | 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. | Day 4 of oral iron supplementation | |
Secondary | 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. | Day 15 of oral iron supplementation | |
Secondary | 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 | Day 18 of oral iron supplementation | |
Secondary | 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 | Day 18 of oral iron supplementation | |
Secondary | 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 | Day 18 of oral iron supplementation | |
Secondary | 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 | Day 18 of oral iron supplementation | |
Secondary | 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 | Day 18 of oral iron supplementation | |
Secondary | 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. | 3 days before oral iron supplementation | |
Secondary | 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. | Day 4 of oral iron supplementation | |
Secondary | 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. | Day 15 of oral iron supplementation. | |
Secondary | 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. | Day 18 of oral iron supplementation |
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