Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Hemoglobin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12-59 months at the time of entry into the study
- •Resident in village for at least 6-months and the caretaker plans to remain in the area for the next year
- •Apparently healthy at the time of entry into the study
排除标准
- •Severe anaemia i.e. Hb concentration <70 g/L (See section 5.5)
- •Taking iron containing haematinic supplements
- •Transfused in the last six months
- •Severely undernourished i.e. anthropometric indices <-3 Z score
结局指标
主要结局
Hemoglobin
时间窗: Start of study (T=0), End of study (T=4months)
Hemoglobin (g/l)
次要结局
- Iron Status(Begin (t=0), End of study (t=4 months))