CTRI/2015/10/006330已完成4 期
A study of an oral nutritional supplementation in picky eating children
Abbott Nutrition International India0 个研究点目标入组 321 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 321
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)Child is > 24 months and <= 48 months of age at visit 1.
- •2)Child of either gender (Male and Female).
- •3)Child has a weight-for-height between 3rd â?? 15th percentiles according to current WHO Growth Charts at visit 1. (WHO Growth Chart 2007)
- •4)Child is a picky eater, defined as meeting at least two of the following criteria. A child, who
- •a.eats only a limited number of foods
- •b.is unwilling to try new foods
- •c.refuses to eat vegetables and/or foods from other food groups
- •d.shows strong food likes and dislikes
- •e.has behaviors that disrupt mealtime
- •5)Child is a habitual milk drinker at least 1 glass (approx. 200ml) of milk daily.
- •6)Child is able to consume foods and beverages orally.
- •7)Childâ??s LG or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period.
- •8)Childâ??s LG or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
- •9)Childâ??s LG or parent(s) is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
- •10)Childâ??s LG or parent(s)is not planning to relocate during the study period
排除标准
- •1)Child has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or LG/parent report.
- •2)Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or LG/parent report.
- •3)Child has a current acute or chronic infection including but not restricted to respiratory infection, diarrhea, Hepatitis B or C, HIV infection or tuberculosis according to medical records or LG/parent report based on the clinicianâ??s judgment.
- •4)Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or LG/parent report.
- •5)Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or LG/parent report.
- •6)Child has been diagnosed with hormonal or metabolic disorders according to medical records or LG/parent report.
- •7)Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Downâ??s syndrome according to medical records or LG/parent report.
- •8)Child has been diagnosed with infantile anorexia nervosa according to medical records or LG/parent report.
- •9)Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or LG/parent report.
- •10)Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or LG/parent report.
- •11)Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
- •12)Child has any other clinically significant medical condition, which in the investigatorâ??s opinion, makes him or her unsuitable for inclusion in the study.
研究者
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