Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa
Brief 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. 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.


Options:
A: Arm Label: Vitamin/mineral fortificant with iron; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Sprinkles® | Arm Label: Vitamin/mineral fortificant without iron; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: vitamin/mineral fortificant without iron | Intervention Type: DIETARY_SUPPLEMENT; Name: Sprinkles®; Assigned to Arm(s): Vitamin/mineral fortificant with iron | Intervention Type: DIETARY_SUPPLEMENT; Name: vitamin/mineral fortificant without iron; Assigned to Arm(s): Vitamin/mineral fortificant without iron
B: Arm Label: MNP+iron and test meal; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Fortified maize porridge (MNP+iron) | Arm Label: MNP+iron+GOS and test meal; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Fortified maize porridge (MNP+iron+GOS) | Intervention Type: DIETARY_SUPPLEMENT; Name: Fortified maize porridge (MNP+iron); Assigned to Arm(s): MNP+iron and test meal | Intervention Type: DIETARY_SUPPLEMENT; Name: Fortified maize porridge (MNP+iron+GOS); Assigned to Arm(s): MNP+iron+GOS and test meal
C: Arm Label: Ready to Use Therapeutic Food (RUTF); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Ready to Use Therapeutic Food (RUTF) | Arm Label: Micronutrient Powder (MNP); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Micronutrient Powder (MNP) | Arm Label: no supplement; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Ready to Use Therapeutic Food (RUTF); Assigned to Arm(s): Ready to Use Therapeutic Food (RUTF) | Intervention Type: DIETARY_SUPPLEMENT; Name: Micronutrient Powder (MNP); Assigned to Arm(s): Micronutrient Powder (MNP)
D: Arm Label: MixMe powder (iron & micronutrients); Type: EXPERIMENTAL; Interventions: Dietary Supplement: fortification with iron and micronutrients | Arm Label: MixMe powder (micronutrients, no iron); Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: fortification with iron and micronutrients | Arm Label: Sprinkles (iron and micronutrients); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Sprinkles | Arm Label: Sprinkles (micronutrients, no iron); Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Sprinkles | Intervention Type: DIETARY_SUPPLEMENT; Name: fortification with iron and micronutrients; Assigned to Arm(s): MixMe powder (iron & micronutrients), MixMe powder (micronutrients, no iron) | Intervention Type: DIETARY_SUPPLEMENT; Name: Sprinkles; Assigned to Arm(s): Sprinkles (iron and micronutrients), Sprinkles (micronutrients, no iron)

Answer: B