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临床试验/NCT01919905
NCT01919905已完成不适用

Fortification of Mozzarella Cheese With Vitamin D3: Effect of High Temperature Cooking and Bioavailability of Vitamin D3

University of Toronto2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012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
100
试验地点
2
主要终点
Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking

研究概览

简要总结

The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin D in industrially fortified mozzarella cheese baked with pizza.

详细描述

With a growing body of evidence, the Institute of Medicine (IOM) conducted a thorough review of all available evidence to publish a report on Dietary Reference Intakes (DRIs) for calcium and vitamin D. In the absence of adequate sun exposure, acquiring the new RDA of 600-800 IU/d for vitamin D through diet alone is difficult. There is a need to increase dietary sources of vitamin D for Canadians.

In a double blind, randomized trial, our objective was to assess the effect of high temperature pizza baking on the bioavailability of vitamin D3 fortified Mozzarella cheese. We tested the following hypotheses, set a priori: 1) vitamin D3 is bioavailable from pizza baked with fortified Mozzarella cheese and heat does not significantly break down vitamin D3; and 2) the change in serum 25(OH)D (from baseline to 10 wk) will be significantly greater in the high-dose vitamin D treated group (28000 IU/wk) compared to the low dose vitamin D-treated group (200 IU/wk).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Healthy males and females between ages 18-70 years

排除标准

  • Use of vitamin D supplements in excess of 1000 IU/day
  • A history of any medical disorder that might effect vitamin D or mineral metabolism
  • Use of medications that could interfere with vitamin D metabolism
  • Potential for sun exposure ( i.e travel to a sunny destination of use of tanning beds) within the month prior to or during the study
  • History of hypercalcemia
  • Unwillingness to return for follow up

结局指标

主要结局

Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking

时间窗: 2 months

Blood 25(OH)D levels will be measured at baseline and at the end of the study between low dose vs. high dose vitamin D group.

次要结局

  • Monitoring dose safety(2 months)

研究者

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

Reinhold Vieth

Clinical Biochemist

University of Toronto

研究点 (2)

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