跳至主要内容
临床试验/NCT01061307
NCT01061307已完成早期 1 期

An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand

Swiss Federal Institute of Technology4 个研究点 分布在 2 个国家目标入组 203 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
203
试验地点
4
主要终点
serum Zn

研究概览

简要总结

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies.

Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.

In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.

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
Double (Participant, Investigator)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Preliminary screening: 650 children of 7-12 y-old children attending the primary school serving a low-income area in Muang district , Satun.(no exclusion criteria).
  • Efficacy trial: 180-200 children, children with the Zn deficiency (serum zinc < 65, 66 and 70 µg/dL in children < 10y, male ≥ 10y and female ≥ 10y)

排除标准

  • Children showing severe iron, zinc or vitamin A deficiency. These children will be excluded from the study and treated according to local policies.
  • Significant chronic medical illness, including gastrointestinal, hematological, hepatic or renal disorders.
  • Low school attendance (<80%).

结局指标

主要结局

serum Zn

时间窗: September 2009-March 2010

serum retinol

时间窗: September 2009-March 2010

serum ferritin

时间窗: September 2009-March 2010

Hemoglobin

时间窗: September 2009-2010

ZPP

时间窗: September 2009- March 2010

次要结局

  • Anthropometry measures(September 2009-March 2010)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验