跳至主要内容
临床试验/NCT01555424
NCT01555424Unknown不适用

Bioavailability of Casein-bound Vitamin D From Fortified Cheese and Its Effects on the Well-being of the Institutionalized Elderly

University of Toronto2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
28
试验地点
2
主要终点
The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults

研究概览

简要总结

The investigators hypotheses is that the consumption of the investigators vitamin D fortified cheese will result in an increase in serum 25-hydroxy vitamin D levels in older institutionalized adults. Also, the consumption of the cheese with the higher amount of vitamin D will result in an improvement in wellbeing scores.

详细描述

The institute of medicine increased the dietary reference intakes of vitamin D for all of the age groups. The Recommended Daily Allowance (RDA) is now 800 IU for older adults over the age of 70, and the Tolerable Upper Level (UL) is 4000 IU daily. Canadians are known to have an inadequate vitamin D status, and older institutionalized adults are particularly susceptible to this. One strategy to correct this is to fortify more kinds of foods with vitamin D. We have already demonstrated that we can get vitamin D into cheddar cheese and it is as biologically available as vitamin D in the liquid supplement.

This new project aims to optimize the fortification process and deliver all of the vitamin D into cheddar cheese, and to measure its bioavailability and related changes in well-being during winter. We will assess the well being of the older institutionalized adults by administering the SF-36v2 health survey.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Lactose intolerance
  • Generally "Healthy", unless disease status deemed clinically significant and unable to participate by the attending physician.

排除标准

  • Hypercalcemia/hypercalciuria
  • Interfering medications
  • Significant sun exposure in the months before and during the study

结局指标

主要结局

The bioavailability of vitamin D from cheddar cheese fortified with vitamin D, in older institutionalized adults

时间窗: 2 months

We are adminstering 2 doses of vitamin D fortified cheese. One cheese contains a higher 28,000 IU/week dose that we expect to see health benefits with. The other cheese contains a 200IU/week dose that is similar to the current milk fortification practice in Canada (100IU per serving).

次要结局

  • A change in wellbeing scores using an SF-36 survey in the older institutionalized adults(2 months)

研究者

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

Reinhold Vieth

Dr.

University of Toronto

研究点 (2)

Loading locations...

相似试验