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临床试验/CTRI/2021/12/038976
CTRI/2021/12/038976招募中4 期

Impact of use of oral nutritional supplement on physical health, mental health and immune health in growing children at risk of undernutrition.

SUN PHARMACEUTICAL INDUSTRIES LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Clinically healthy children between 2-6 years of age and at risk of undernutrition defined as those between less than -1 and â??2 standard deviations of the WHO Child Growth Standards Median for weight for age.
  • 2. Children who are picky eaters, defined as below, between 2-6 years of age and at risk of undernutrition.
  • 3. Parents of children willing to give written informed consent
  • Picky eating was defined as having at least two of the following:
  • - eating only a limited number of foods;
  • - being unwilling to try new foods;
  • - refusing to eat vegetables and/or foods from other food groups;
  • - showing strong food likes and dislikes;
  • - displaying behaviour that disrupted mealtimes

排除标准

  • 1. Children less than 2 years and greater than 6 years of age will be excluded.
  • 2. Children with moderate or severe malnutrition
  • 3. Lactose intolerant children
  • 4. Gluten intolerant children
  • 5. Hypersensitivity to any ingredient in product
  • 6. History of preterm delivery
  • 7. Birth weight less than 2500 or greater than 4000 g
  • 8. Ongoing or Recurrent infections, diarrhoea, known case of acute and chronic hepatitis B or C, HIV or tuberculosis, or diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases, or diagnosis of congenital or genetic disorder or infantile anorexia nervosa.
  • 9. Children under medications or agents that could modulate body weight including but not limited to diuretics, appetite stimulants, steroids, and growth hormones
  • 10. Children with of history of consumption of any other nutritional supplement within last 3 months of enrolment in study.
  • 11. Children who had an obese parent defined as measured or self-reported BMI greater than equal to 28 kg/m2; to minimise the impact of genetic and family environmental influences on childhood overweight development.

研究者

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