NCT03818594已完成不适用
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1
Nutrition Institute, Slovenia1 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2019年1月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Difference between vitamin D serum levels in winter and in summer season will be determined
研究概览
简要总结
Seasonal variations in vitamin D status will be determined on a cohort of Slovenian adults using longitudinal study design, and association between vitamin D status and different Caucasian phototypes, skin colour and melanin index investigated .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed consent form (ICF),
- •Caucasian race
- •Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
- •Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources
- •Willingness to follow all study procedures
排除标准
- •Pregnancy or breastfeeding,
- •Known or suspected allergy to any ingredient of the tested products in Part 2,
- •Pronounced avoidance of sunshine (eg reporting of allergy to the sun)
- •Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion,
- •Special dietary habits used by a small part of the population (veganism, low-carb hihg-fat diet, caloric restriction diet, note: vegetarians are not excluded)
- •Diets prescribed by the medical profession
- •Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases
- •Other diseases and conditions that affect the absorption and synthesis of vitamin D
- •Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium),
- •The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D,
- •Visiting the solarium in the last three months before joining the survey,
- •Mental incapacity that precludes adequate understanding or cooperation.
结局指标
主要结局
Difference between vitamin D serum levels in winter and in summer season will be determined
时间窗: 2 years
Vitamin D serum level will be measured once in winter (December - January) and once in summer season (August-September) for each individual. The study will be performed over two consecutive years.
次要结局
- Correlation of vitamin D serum levels with melanin index(2 years)
- Correlation of vitamin D serum levels with Fitzpatrick skin phototype(2 years)
- Correlation of vitamin D serum levels with skin colour measured in CIE Lab colour space(2 years)
研究者
研究点 (1)
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