CTRI/2018/12/016576已完成未知
A Randomized, Open-label, Controlled, Parallel-group Study to Determine the Impact of Nutritional Supplement in 4-6 year-old children. - NI
utricia International Pvt Ltd0 个研究点目标入组 216 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 216
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
- •The inclusion criteria for the study are as follows:
- •1. Subject (boy or girl), 4-6 years of age, and residing in India;
- •2. For subject 4-5 years of age, WHO MGRS 2006 weight-for-age z-scores between -1 and -2 and for subjects 5-6 years of age, IAP 2015 weight-for-age z-scores between -1 and -2;
- •3. The subject to remain in the same locality for the duration of the study (up to 3 months);
- •4. Subject with good general and mental health in the investigatorâ??s opinion;
- •5. Subjectâ??s parent/LAR understand and are willing, able and likely to comply with all study procedures and restrictions;
- •6. Subjectâ??s parent/LAR are willing to accommodate daily home visits by the study personnel for provision of study product;
- •Subjectâ??s parent/LAR willing to sign the informed consent form (ICF)
排除标准
- •1. Subject with recent history (within 3 months prior to signing ICF) of surgery, serious infections, or injuries.
- •2. Subject who is malnourished, immunocompromised.
- •3. Subject with known or suspected intolerance or hypersensitivity to the study product (or closely related compounds) or any of their stated ingredients.
- •4. Subject with lactose intolerance and/or aversion to drinking milk
- •5. Subject who needs to be fed with a special diet OR who needs to be fed with a diet which is different from that advised by the study center nutritionist OR taking a nutritional supplement (with average consumption of >=10%) in the past 3 months prior to screening
- •6. Subject on restrictions that prevent adherence to the diet plan, which is advised by the study center nutritionist during dietary advice
- •7. Subject with known food allergies as reported by parent/LAR
- •8. Subject currently participating, or has participated in a drug/device study or a nutritional program run by the local government or NGO within a period of 30 days prior to screening
- •9. Child-in-care (CiC): A child who has been placed under the control or protection of an agency, organization, institution or any entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed LAR
- •10. Subject related to an employee of the sponsor or the study site staff
研究者
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