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临床试验/NCT02495584
NCT02495584已完成不适用

D-Light Intervention: A Randomised Controlled Human Intervention Study to Assess the Impact of Vitamin D From Milk and Supplements on Functional Health Outcomes and Future Vitamin D Synthesis From UV Exposure

University of Ulster2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Change in vitamin D status (25-hydroxyvitamin D serum concentration)

研究概览

简要总结

Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude, increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status, with lower levels noted in the winter months. Variations in vitamin D status have been known to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin D during the winter months, causing us to rely on dietary sources. The aim of this intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this intervention will affect subsequent dermal synthesis of vitamin D from UV exposure. Participants will be recruited from the local community. Blood samples will be collected from each participant at two timepoints (September/October and March/April). Pre- and post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences will be measured, in addition participants will undergo a dual energy x-ray absorptiometry (DXA) scan to assess body composition and bone mineral density. Information on general health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will be collected. Following the dietary intervention, a subset of participants will be invited to participate in a follow-up study, examining UV exposure during the summer months, when they will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2 additional blood samples.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20-40 years old
  • Apparently healthy
  • Living on the island of Ireland

排除标准

  • Below 20 years and aged 40 years or above
  • Not living on the island of Ireland
  • Pregnant or lactating women and those planning to become pregnant
  • Individuals who have been taking a vitamin D or calcium containing supplement in the previous three months
  • Those with food intolerances or allergies that would affect their ability to consume study milk
  • Individuals following a diet which excludes milk (e.g. vegans)
  • Those with a diagnosed chronic medical condition or on prescribed medication known to effect vitamin D metabolism
  • Those who are planning a sun holiday during the winter months (Oct-Mar)
  • Adults with learning, or any other difficulties that would prevent them from completing the study protocol

结局指标

主要结局

Change in vitamin D status (25-hydroxyvitamin D serum concentration)

时间窗: Baseline + post-intervention (24weeks)

Blood analysis

次要结局

  • Change in body composition(Baseline + post-intervention (24weeks))
  • Change in muscle strength(Baseline + post-intervention (24weeks))
  • Change in inflammation status(Baseline + post-intervention (24weeks))
  • Change in lipid profile(Baseline + post-intervention (24weeks))
  • Change in glucose levels(Baseline + post-intervention (24weeks))
  • Change in insulin concentrations(Baseline + post-intervention (24weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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