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临床试验/NCT02212223
NCT02212223已完成不适用

Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)

University of Helsinki1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2014年9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
147
试验地点
1
主要终点
Serum 25-hydroxyvitamin D (25(OH)D) concentrations

研究概览

简要总结

Insufficient intake of vitamin D is a public health problem, affecting about 40% of the Finnish population in the winter. Vitamin D has a wide range of health effects: in addition to its effect on bone, it is known to affect inflammatory response among other things. The sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements. In Finland and in Northern Europe vitamin D is formed in the skin only from March to October. This alone is not sufficient to cover the need for year-round, because vitamin D storage is used in a few months. During the winter months the only sources of vitamin D are diet and vitamin preparations. Current vitamin D recommendations are usually based on studies in white population. However, there can be a difference in the need of vitamin D and in vitamin D metabolism between different population groups. More research evidence is needed from the northern countries. The aim of this study is to evaluate the vitamin D need in Somali immigrant population and in original Finnish population. The hypothesis is that the Somalis need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original Finnish population.

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, Investigator)

入排标准

年龄范围
21 Years 至 66 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • woman between 21-66 years of age
  • belongs to original Finnish population or to Somali immigrant population
  • healthy (= no disease requiring medication)
  • lives in the metropolitan area

排除标准

  • pregnant or breastfeeding
  • has traveled to a sunny destination or destination near the equator during the previous month
  • plans to travel to a sunny destination or destination near the equator in the next 6 months
  • has used a tanning bed during the previous month
  • plans to use a tanning bed in the next 6 months
  • the subject's blood 25-hydroxy-vitamin D level (25 (OH) D), exceeds 100 nmol / L or is less than 30 nmol / L at baseline in the screening phase.

结局指标

主要结局

Serum 25-hydroxyvitamin D (25(OH)D) concentrations

时间窗: Change from baseline in serum 25(OH)D concentration at 3 and 6 months

The effect of ethnicity on the serum 25(OH)D concentration response to vitamin D supplementation will be investigated.

次要结局

  • Serum calcium concentration(Change from baseline in serum calcium concentration at 3 and 6 months)
  • Serum parathyroid hormone (PTH) concentration(Change from baseline in serum PTH concentration at 3 and 6 months)

研究者

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

Christel Lamberg-Allardt

Associate Professor

University of Helsinki

研究点 (1)

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