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评估健康儿童补钙情况的随机试验:行业赞助与研究结果之间的关系。

Randomized trials assessing calcium supplementation in healthy children: relationship between industry sponsorship and study outcomes.

作者信息

Nkansah Nancy, Nguyen Thao, Iraninezhad Hoda, Bero Lisa

机构信息

University of California-San Francisco, 155 North Fresno Street Suite 224, Fresno, CA 93701, USA.

出版信息

Public Health Nutr. 2009 Oct;12(10):1931-7. doi: 10.1017/S136898000900487X. Epub 2009 Mar 2.

DOI:10.1017/S136898000900487X
PMID:19254426
Abstract

OBJECTIVE

To explore the relationship between industry sponsorship of Ca supplementation studies in healthy children and study outcomes.

DESIGN

An electronic search for published randomized controlled trials (RCT) was conducted. We collected data on study design features aimed at reducing bias, statistical significance of results, authors' conclusions and financial sponsorship of study. We used Fischer's exact test to examine associations between sponsorship and study results and conclusions.

SUBJECTS

Healthy children between the ages of 9 and 18 years.

RESULTS

Nineteen trials met our inclusion criteria. Seventeen out of nineteen studies reported a statistically significant improvement of supplementation on bone mineral density. Subjects in eight of the seventeen studies had a baseline daily Ca intake of 800-1300 mg. There was no significant association between study design features and the results or conclusions of the studies. Three studies received government funding, two of which (66.7%) concluded in favour of additional supplementation. Sixteen studies were either industry-funded or had mixed industry funding, thirteen (81.3%) of which had a conclusion supporting Ca supplementation in children. There was no significant association between study sponsorship and authors' conclusions.

CONCLUSIONS

The majority of RCT assessing the effects of Ca supplementation in healthy children are industry-funded and support Ca supplementation. The clinical significance of the outcomes measured in Ca supplementation studies should be considered when examining associations between study design and results. Further non-industry funded research is needed to thoroughly assess the impact of funding on authors' conclusions in nutrition research.

摘要

目的

探讨健康儿童钙补充研究的行业资助与研究结果之间的关系。

设计

进行电子检索已发表的随机对照试验(RCT)。我们收集了旨在减少偏倚的研究设计特征、结果的统计学显著性、作者结论以及研究的资金资助等数据。我们使用费舍尔精确检验来检验资助与研究结果及结论之间的关联。

研究对象

9至18岁的健康儿童。

结果

19项试验符合我们的纳入标准。19项研究中有17项报告补充剂对骨密度有统计学显著改善。17项研究中的8项研究对象的钙日摄入量基线为800 - 1300毫克。研究设计特征与研究结果或结论之间无显著关联。3项研究获得政府资助,其中2项(66.7%)得出支持额外补充剂的结论。16项研究由行业资助或有行业混合资助,其中13项(81.3%)得出支持儿童补钙的结论。研究资助与作者结论之间无显著关联。

结论

评估健康儿童补钙效果的大多数随机对照试验由行业资助并支持补钙。在研究设计与结果之间的关联时,应考虑补钙研究中所测量结果的临床意义。需要进一步开展非行业资助的研究,以全面评估资助对营养研究中作者结论的影响。

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