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: Dietary supplement; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Corn Soya Blend+ | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Corn Soya Blend+; Assigned to Arm(s): Dietary supplement
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Other: Lyophilized meat | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Cereal | Intervention Type: OTHER; Name: Lyophilized meat; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Cereal; Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: NaFeEDTA, Electrolytic Iron; Assigned to Arm(s): N/A

Answer: A