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A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children.

2018年1月10日 更新者:GlaxoSmithKline

A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children Aged 6 to 12 Years Receiving Nutritional Supplement With or Without Micronutrient Fortification

This methodology study will evaluate the sensitivity in using sitting knee digital caliper to measure changes in sitting knee length from over a 12-week study period amidst children in the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are receiving nutritional supplementation with micronutrients or without micronutrients.

研究概览

研究类型

介入性

注册 (实际的)

109

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bangalore、印度、560043
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 12年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Children (participants), both boys and girls, aged 6 to 12 years.
  • Participant height to be within the 25th to the 75th percentile of the standard height average in Indian children population
  • Participant will agree not to take any other nutritional supplements products during the study except the trial supplement

Exclusion Criteria:

  • Participant has any of the following medical conditions: Genetic disorders, chronic disease, metabolic disorders, endocrine disorders, immobilisation, and miscellaneous
  • Participant who in the past 6 months has used dietary or nutritional supplements with micronutrient fortification, or any form of dietary or herbal supplement intended to increase micronutrient intake, at a frequency of greater than 3-4times per month.
  • Participant receiving any supplements (such as calcium, iron and/or multivitamin at the time of screening).
  • Children (Participant) in Care are not allowed to participate in the study.
  • Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Health conditions that would affect food metabolism including the following food allergies, kidney disease, liver disease, and/or gastrointestinal diseases (e.g. irritable bowel syndrome, celiac disease, peptic ulcers).
  • Use of concomitant medications that, in the opinion of the Principal Investigator (PI), might interfere with the outcome of the study or increases the risk of the participant, including corticosteroids (systemic or inhaled) and any medication for any behaviour-related disorders and/or stimulants.
  • Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder, including history of alcohol or substance abuse, that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the PI/medical examiner.
  • Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Personnel: Currently, the participant's parents/legal guardian is an employee of the Sponsor or the study or members of their immediate family.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Nutritional supplement with micronutrient
Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily
Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve
假比较器:Nutritional supplement without micronutrient
Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily
Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.
大体时间:Baseline to Week 12
To evaluate the sensitivity of a sitting knee digital caliper to measure changes in sitting knee length from Baseline to Week 12 in a community-based study in the presence of nutritional supplementation with or without micronutrients.
Baseline to Week 12

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline to Week 12 in Z-score based on the standing height
大体时间:Baseline-Week 12
Comparison of standing height and sitting knee height to asses growth
Baseline-Week 12
Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper
大体时间:Baseline-Week 8
To assess the relationship between changes from Baseline to Week 8 in sitting knee length and standing height in the presence of nutritional supplementation with or without micronutrients
Baseline-Week 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年10月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月13日

研究注册日期

首次提交

2014年7月24日

首先提交符合 QC 标准的

2014年7月24日

首次发布 (估计)

2014年7月28日

研究记录更新

最后更新发布 (实际的)

2018年1月12日

上次提交的符合 QC 标准的更新

2018年1月10日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 201133
  • RH01817 (其他标识符:GSK)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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