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临床试验/NCT04343508
NCT04343508已完成不适用

Study to Evaluate the Efficacy of Fortified Rice on Hemoglobin Levels and Levels of Vitamins and Minerals in Healthy Asian Migrant Workers in Singapore

DSM Nutritional Products, Inc.2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2018年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
133
试验地点
2
主要终点
Hemoglobin status

研究概览

简要总结

The study is a single center, open label, nutrition intervention study. Healthy adult male working at a Singapore construction site are included if they fulfill inclusion and exclusion criteria. Volunteers receive fortified rice for their daily lunch and dinner each day of the week (i e 14 meals/week) over six months. Nutrition status in blood is measured at baseline and after six months of fortified rice consumption.

详细描述

The study is a single center, open label, uncontrolled longitudinal nutrition intervention study. Migrant construction workers of either Bangladeshi or Indian ethnicity from a single dormitory in Singapore volunteer to participate at the study. Only eligible workers are included in the study if they fulfilled all inclusion and exclusion criteria; 20 and 51 years old, a BMI between 17.0 to 27.5 kg/m2, willing to adhere to the study procedure for at least six months, and sign informed consent, are free of current medical and/or chronic/non communicable diseases, no history of heavy smoking or alcohol consumption. The eligible subjects receive fortified rice for their daily lunch and dinner each day of the week (i e 14 meals/week) over six months. The nutrient levels per 100 g fortified rice contain 150 µg vitamin A (Vitamin A palmitate), 0.5 mg vitamin B1 (thiamin mononitrate), 7 mg vitamin B3 (niacin amide), 0.6 mg vitamin B6 (pyridoxine hydrochloride), 1 µg vitamin B12 (cyanocobalamin), 130 µg folic acid, 4 mg iron (ferric pyrosphosphate), and 6 mg zinc (zinc oxide). At baseline and after 6 months of intervention, BMI and vital signs such as blood pressure, pulse and body temperature are collected. Also, 10 ml venous blood is sampled at baseline and after 6 months of intervention and subsequently tested for hemoglobin, serum folate, and serum zinc, serum ferritin and serum vitamin B12 status. In a small subset of the migrant construction workers, an extra 5 ml blood sample is taken for homocysteine testing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 20 Years to 51 Years
  • Indian or Bangladeshi ethnic origin
  • BMI of 17.0 to 27.5 kg/m2
  • Working at the construction site and continuing for 6 months after enrollment
  • Willing and able to adhere to study procedures
  • Signed the informed consent form

排除标准

  • Conditions or diseases that the investigator considers to be not appropriate to enter the study
  • Chronic illness
  • History of heavy smoking (more than 10 cigarettes/day continuously for two years or more (self-reported) )
  • Unable to understand informed consent (translated to Tamil and Bangladesh at basic literacy level)

结局指标

主要结局

Hemoglobin status

时间窗: From baseline to 6 months

Hemoglobin concentration in blood

次要结局

  • Zinc status(From baseline to 6 months)
  • Homocysteine status(From baseline to 6 months)
  • BMI(From baseline to 6 months)
  • Folate status(From baseline to 6 months)
  • Iron status(From baseline to 6 months)
  • Vitamin B12 status(From baseline to 6 months)

研究者

发起方
DSM Nutritional Products, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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