跳至主要内容
临床试验/NCT02525003
NCT02525003已完成不适用

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)

University of Helsinki1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

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

研究组 & 干预措施

Group 1: placebo

Placebo Comparator

Group 1: daily dose of regular bread (87 g/d) and placebo pill (0 µg of vitamin D/d) for 8 weeks

Group 4: Vitamin D2-fortified bread

Experimental

Group 4: D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks

干预措施: Vitamin D2 fortified bread (Other)

Group 3: Vitamin D3 supplement

Experimental

Group 3: daily dose of regular bread (87 g/d) and D3 supplement (25 µg of vitamin D3/d.) for 8 weeks

干预措施: Vitamin D3 (Dietary Supplement)

Group 2: Vitamin D2 supplement

Experimental

Group 2: daily dose of regular bread (87 g/d) and D2 supplement (25 µg of vitamin D2/d.) for 8 weeks

干预措施: Vitamin D2 (Dietary Supplement)

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

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

Christel Lamberg-Allardt

Professor

University of Helsinki

研究点 (1)

Loading locations...

相似试验