Work Package 5: The Potential Advantages and Limitations of Use of Novel Food-based Solutions for Prevention of Vitamin D Deficiency. 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
- 41
- 试验地点
- 1
- 主要终点
- Serum total 25-hydroxyvitamin D (25(OH)D)
研究概览
简要总结
Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However, in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in winter. Between November and March, dietary or supplementary vitamin D intake is essential to maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a few natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2 (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly used in fortified products in Europe, although the production of plant-derived vitamin D2 would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3 are limited. An important consideration is whether food-based sources of vitamin D2 are effective in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The investigators investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast in bread in terms of efficacy of raising total S-25(OH)D) as well its possible effects on S-25(OH)D2, S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations compared with D2 and D3 supplementation in a randomized placebo-controlled trial in young healthy females during winter in Finland.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •good general health (no continuous medication),
- •Caucasian origin,
- •body mass index (BMI) <30 kg/m2
- •age 20-40 years
排除标准
- •diagnosed celiac disease or cereal allergy
- •a vacation in a sunny place during the study or within the preceding 2 months
- •regular use of vitamin D supplements >15 µg/d
- •pregnancy or breastfeeding during the study
结局指标
主要结局
Serum total 25-hydroxyvitamin D (25(OH)D)
时间窗: Change from baseline in total 25(OH)D concentration at 4 and 8 weeks
The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D concentration
次要结局
- Serum 25-hydroxyvitamin D2 (25(OH)D2)(Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks)
- Serum parathyroid hormone (PTH) concentration(Change from baseline in serum PTH concentration at 4 and 8 weeks)
- Serum calcium concentration(Change from baseline in serum calcium concentration at 4 and 8 weeks)
- Serum 25-hydroxyvitamin D3 (25(OH)D3)(Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks)
研究者
Christel Lamberg-Allardt
Professor
University of Helsinki
