Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in vitamin D serum concentration after 8 weeks of supplementation
研究概览
简要总结
The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in adult population will be determined. It will provide insights into the influence of formulation on vitamin D absorption.
A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65 years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in Part 1 of the study, after completion of winter sampling.
Study subjects will be randomised into four study groups (at least 18 subjects per study group). Three different treatments will be compared with a control group, which will not receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C) Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are commercially available. Prior to study, actual level of vitamin D will be determined using appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two months, in all three groups. Second serum vitamin D level will be determined on last day of the treatment, and compared with pre-treatment vitamin D level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •vitamin D suboptimal status
- •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 high-fat (LCHF) 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
Change in vitamin D serum concentration after 8 weeks of supplementation
时间窗: 8 weeks
次要结局
未报告次要终点