Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
Brief Summary: Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification.

Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya.

Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study.

Study design:

The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks.

Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups.

Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories.

Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration \<12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of \>8.3mg/L. Infection will be assessed by raised CRP (\>10mg/L) as an indicator of acute inflammation and presence of malaria.


Options:
A: 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
B: Arm Label: Programme; Type: EXPERIMENTAL; Interventions: Other: MNP + IYCN counseling + cooking demonstrations | Arm Label: Controle; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: MNP + IYCN counseling + cooking demonstrations; Assigned to Arm(s): Programme
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: 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

Answer: A