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临床试验/NCT02678364
NCT02678364已完成不适用

A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults

University College Cork1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter

研究概览

简要总结

While there have been a considerable number of studies on the impact of additional vitamin D in the diets of hens on the resulting egg vitamin D content, the effect of consumption of such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been tested in a RCT.

详细描述

The aim of this study was to investigate the effect of consumption of vitamin D3 versus 25-hydroxyvitamin D3 biofortified eggs on winter serum 25(OH)D in adults using a 8-wk randomized controlled trial. This research will provide new data on the potential of vitamin D enriched eggs as a food-based strategy for prevention of vitamin D deficiency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consenting white men and women aged 45-70 years

排除标准

  • consumption of vitamin D-containing supplements throughout the study. planning to take a winter vacation (during the course of the 8-wk intervention) - to a location at which either the altitude or the latitude would be predicted to result in significant cutaneous vitamin D synthesis from solar radiation
  • planning to use tanning facilities of any type.
  • a severe medical illness,
  • allergy to egg products,
  • medically advised to limit egg intake in relation to managing hypercholesterolemia,
  • hypercalcaemia,
  • known intestinal malabsorption syndrome,
  • excessive alcohol use,
  • the use of medications known to interfere with vitamin D metabolism

结局指标

主要结局

Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter

时间窗: up to 8 weeks

次要结局

  • Serum parathyroid hormone(0 weeks and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin D. Cashman

Professor of Food and Health

University College Cork

研究点 (1)

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