Improving Iron Status of Children: Potential of Amaranth
Condition: Anemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

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.
    

Detailed description: 
      Background and Rationale The most severe problems of micronutrient deficiency are found
      amongst resource poor, food insecure and vulnerable households in developing countries. From
      the 1999 Kenya national survey on micronutrients, it was estimated that seven out of every
      ten children under five years are likely to be anaemic (Hb<110g/L) and nearly half (43.2%)
      were iron deficient.

      The period of complementary feeding is a critical and vulnerable time in the growth and
      development of children. Poor complementary feeding practices combined with chronic food
      insecurity are found to substantially contribute to the widespread multiple micronutrients
      deficiencies in developing countries.

      A recent food consumption study in Mwingi district in Kenya, showed that ugali (stiff maize
      porridge) was the primary complementary food. The use of ugali as the primary complementary
      food suggests that the children may be at risk of inadequate micronutrient intake among
      children 12-23 months. These findings underscore the need to establish solutions to increase
      dietary diversity and to promote use of foods that are rich in nutrients such as iron.

      Amaranth grain offers the prospect of considerably improving dietary food diversification in
      semi arid areas. Agronomic investigations indicate that amaranth grain contains high iron
      concentrations ranging from 7.6-27 mg/100g of edible portion. Amaranth grain is a hardy crop
      and can withstand low rainfall. As such, grain amaranth may offer a viable solution in
      semi-arid areas where iron rich foods such as animal and fortified products are not readily
      available.

      This study has therefore been designed to investigate the efficacy of porridge made from
      amaranth enriched maize flour in improving the diet quality and iron intake in children 12-59
      months in a semi-arid area in Kenya. Home fortification of complementary foods using
      micronutrient powders has also been shown to reduce iron deficiency anaemia in many
      resource-poor settings including Kenya.

      Objectives The primary objective of this study is To determine the efficacy of maize porridge
      enriched with amaranth grain flour on improving iron intake and status in children 12-59
      months in a semi arid area in Kenya.

      In addition we aim:

        -  To determine the efficacy of amaranth grain enriched maize porridge compared to maize
           porridge fortified with micronutrient multi-mix powder (MixMe™) to improve iron status
           and intake of children 12-59 months.

        -  To determine the iron, zinc and nutritional status of children 12-59 months.

      Hypothesis

      We hypothesize that:

        -  Children receiving amaranth grain enriched maize porridge will show greater improvement
           in iron status than those receiving plain maize porridge.

        -  Children receiving amaranth enriched maize porridge will show less improvement in iron
           status than those receiving maize porridge fortified with micronutrient multi-mix powder
           (MixMe™).

      Study Area and Population The study will be conducted in Migwani within the larger Mwingi
      District in Eastern Kenya. This area falls within the arid and semi arid area (ASAL) and thus
      experiences food shortage for most part of the year. The study population will comprise
      children aged 12-59 months. Mothers or principal caretakers will be interviewed on behalf of
      the children.

      Study Design The study will have a randomized controlled trial design conducted over a period
      of 4 months/16 weeks.

      The administrative study area has been purposively selected as it falls within an
      agro-ecological zone of a semi-arid area. Random sampling out of a total of six Sub-locations
      in Migwani will be done to get 4 Sub-locations. Within a Sub-location, individual sampling
      units (Household with a child aged 12-59 months) will be selected using a random walk method
      until the required sample size of 68 children is achieved per Sub-location. Children who meet
      the inclusion criteria shall be randomly assigned to one of the following treatment groups:

        1. Maize porridge enriched with amaranth grain flour

        2. Maize porridge fortified with a multiple micronutrient powder (MixMe™)

        3. Plain maize porridge
    

Intervention name(s): Maize and Amaranth
Intervention type(s): Dietary Supplement
Intervention description(s): 80g porridge per day, 5 days a week, for 16 weeks (4 months)
Other intervention name(s): Mix Me micro-nutrient powder
Intervention MeSH terms: Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Complementary foods; Amaranth; Food Based approaches; Iron Deficiency anemia; Arid Areas; Africa