Formulation and Production of Macro- and Micronutrient Sachets for Home Fortification and Evaluation of Their Efficacy on Pregnant Mothers and Children Aged 6-60 Months in Sistan Baloochestan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Weight gain during pregnancy
研究概览
简要总结
The aim of the present study is formulation and production of sachets containing macronutrients and micronutrients to enrich food at home and evaluate its effectiveness on pregnant mothers and children aged 6 to 60 months living in Sistan and Baluchestan province
详细描述
This study is conducted in three steps. At first, fortification sachets are formulated and produced in accordance with international recommendations for micronutrients (vitamins A, D, zinc, and iron) and macronutrients for use in normal home conditions. In the second step, efficacy of fortified sachets are evaluate in three subgroups including pregnant mothers, 6-24 months and 2-5 years old children. Nutritional, anthropometrical and biochemical indices are evaluated at the beginning and after 6-9 months intervention. At the third step, costs and cost-effectiveness of the intervention in each of the studied groups in comparison with the usual program for that age group in the health care system of the country is determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women
- •being in the first trimester of pregnancy
- •free of chronic diseases before pregnancy
- •no intention to change residence until delivery
- •Children 6 to 23 months
- •age 6 to 7 months
- •no intention to change residence or migrate in the next 12 months
- •free of acute or chronic illness
- •Children 2 to 5 years (60-24 months)
- •age 24 to 48 months
- •no intention to change residence or migrate in the next 6-12 months
- •free of acute or chronic diseases
排除标准
- •Pregnant women
- •premature termination of pregnancy
- •change of residence before delivery
- •Children 6 to 23 months
- •change of residence before delivery
- •Children 2 to 5 years (60-24 months) -change of residence before delivery
研究组 & 干预措施
Pregnant women receiving fortification sachets
pregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months
干预措施: micro-and macro-nutrients fortified sachets (Dietary Supplement)
6-24 months old children receiving fortification sachets
6-24 months old children receiv daily fortified sachets containing micro-and macronutrients for 6-9 months
干预措施: micro-and macro-nutrients fortified sachets (Dietary Supplement)
2-5 years old children receiving fortification sachets
2-5 years old children receive daily fortified sachets containing micro-and macronutrients for 6-9 months
干预措施: micro-and macro-nutrients fortified sachets (Dietary Supplement)
结局指标
主要结局
Weight gain during pregnancy
时间窗: 6-9 months
Weight difference at the beginning and end of pregnancy
Birth weight
时间窗: 6-9 months
Measured weight (kg) at the first day of life
Weight for height
时间窗: 6-9 months
The ratio of weight (kg) to height(m)
Weight for age
时间窗: 6-9 months
Measured weight (kg) in a specific age (year)
次要结局
- 25-hydroxyvitamin D (nmol/L)(6-9 months)
- Hemoglobin (g/dL)(6-9 months)
- Serum B12 (pg/mL)(6-9 months)
- Serum folate (ng/mL)(6-9 months)
- Serum ferritin (ng/mL)(6-9 months)
- Serum retinol (micromol/L)(6-9 months)
- Serum zinc (microg/dL)(6-9 month)
- Apgar score(6-9 months)
研究者
Tirang R. Neyestani, Ph.D.
Prof.
National Nutrition and Food Technology Institute