Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
Brief Summary: The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.


Options:
A: Arm Label: Experimental: Ready to Use Terapeutic Food (RUTF); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP | Arm Label: Multi Micronutrient Powder (MNP); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP | Arm Label: no supplement; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Dietary Supplement: Nutrition supplement with RUTF or MNP; Assigned to Arm(s): Experimental: Ready to Use Terapeutic Food (RUTF), Multi Micronutrient Powder (MNP)
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: 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)
D: Arm Label: Micronutrient Powder (MNP) + Zn/Fe; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: MNP + Zn/Fe | Arm Label: MNP + Zn; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: MNP + Zn | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: MNP + Zn/Fe; Assigned to Arm(s): Micronutrient Powder (MNP) + Zn/Fe | Intervention Type: DIETARY_SUPPLEMENT; Name: MNP + Zn; Assigned to Arm(s): MNP + Zn | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Control

Answer: D