Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)
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
- 是
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
Christel Lamberg-Allardt
Associate Professor
University of Helsinki
