Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya
Brief Summary: Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food.

The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants.

Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.


Options:
A: Arm Label: Low-dose iron as NaFeEDTA; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Low-dose iron as NaFeEDTA | Arm Label: Conventional dose iron as ferrous salt; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Conventional dose iron as ferrous salt | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Low-dose iron as NaFeEDTA; Assigned to Arm(s): Low-dose iron as NaFeEDTA | Intervention Type: DIETARY_SUPPLEMENT; Name: Conventional dose iron as ferrous salt; Assigned to Arm(s): Conventional dose iron as ferrous salt | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
B: 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)
C: Arm Label: Maize porridge with Amaranth; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Maize and Amaranth | Arm Label: Maize flour with multiple micronutrients; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Maize and Amaranth | Arm Label: Maize Porridge; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Maize and Amaranth | Intervention Type: DIETARY_SUPPLEMENT; Name: Maize and Amaranth; Assigned to Arm(s): Maize Porridge, Maize flour with multiple micronutrients, Maize porridge with Amaranth
D: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Other: Nutritional Counselling and Education | Arm Label: B; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Micronutrient Supplementation without Zinc | Arm Label: C; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Micronutrient Supplementation with Zinc | Intervention Type: DIETARY_SUPPLEMENT; Name: Micronutrient Supplementation without Zinc; Assigned to Arm(s): B | Intervention Type: DIETARY_SUPPLEMENT; Name: Micronutrient Supplementation with Zinc; Assigned to Arm(s): C | Intervention Type: OTHER; Name: Nutritional Counselling and Education; Assigned to Arm(s): A

Answer: B