跳至主要内容
临床试验/NCT03318029
NCT03318029已完成不适用

A Systems Biology Approach to the Interaction Between Vitamin D Supplementation and Sunlight Exposure in Brazilian Women Living in Opposite Latitudes (The D-SOL Study).

University of Surrey4 个研究点 分布在 2 个国家目标入组 136 人开始时间: 2016年10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
136
试验地点
4
主要终点
Change from baseline vitamin D status at 12 weeks of vitamin D supplementation

研究概览

简要总结

There is a consensus that vitamin D deficiency is a public health issue because of its implications in several diseases including, osteopenia, osteomalacia, heart disease, diabetes (type I and II), inflammatory diseases, multiple sclerosis and rheumatoid arthritis. Studies in sunny countries have shown that vitamin D deficiency is a common phenomenon, despite the abundance of sunlight in these places, which shows the influence of diet, skin pigmentation, cultural habits and also genetic factors on the metabolism of this vitamin. Thus, the study hypothesis is that vitamin D supplementation is required to obtain the optimal serum concentration in Brazilian people living both in Brazil and in the United Kingdom and that this response is dependent on the initial levels, being influenced by sunlight exposure, skin pigmentation, diet and polymorphisms of the vitamin D receptor gene. Two controlled, randomized, double-blind clinical trials were held (one in the UK and the other in Brazil) over a period of 12 weeks, with female subjects, Brazilian, aged 20 to 59 years. The women selected were divided into two groups: Placebo Group and Supplemented Group, the latter received vitamin D 600 IU. After the analysis of the effect of vitamin D supplementation compared to placebo, the investigators propose to analyse genome-wide transcriptomic expression in order to associate specific signal transduction and metabolic pathways to respective vitamin D responses. and a genetic risk score based on polymorphisms will be constructed. The 'systems level' approach will enable us to identify differences in gene expression and whether this explains why some individuals are 'good' responders or 'poor' responders to vitamin D supplementation. This is the first study that will examine two population groups of the same ethnic group and sex, living in different countries, with identical design studies. Our results first will determine how important supplementation and exposure to sunlight are for the serum level of vitamin D by comparing directly, using the same methodology, people living in different latitudes, as well as the genetic influence on the response to supplementation. The data will also provide both countries key data about the need to reconsider new revisions to dietary recommendations for vitamin D in adults.

详细描述

During this study the subjects were asked to visit the Clinical Investigation Unit, FHMS, University of Surrey in the UK or the Research Clinic, Faculty of Nutrition, Federal University of Goiás in Brazil, on two occasions, at the beginning of the study for baseline measurements and at the conclusion of the study. The investigators examined four to eight fasted subjects per study morning. Trial visits lasted approximately 45-60 minutes each and took place in the morning (7am-11am). Participants were offered refreshments at the end of their appointment.

If participants wished to be screened for participation in the study, they would receive the Participant Information Sheet and then be checked against the study inclusion and exclusion criteria using a 'Screening Questionnaire' , administered by a member of the D-SOL Research Team by phone or self-reported by email.

Baseline visit:

If eligible, participants were invited for the baseline visit. At this visit, they were first given time to discuss the Participant Information Sheet and any questions they may have regarding the study. Informed consent was discussed and participants were asked to sign the consent form, and offered a copy to keep for themselves.

Baseline procedures:

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Brazilian nationality Living in the UK or in Brazil for more than 2 months

排除标准

  • Currently receiving treatment for medical conditions that are likely to affect vitamin D metabolism ( osteoporosis therapy, anti-estrogens treatment, antiepileptic drugs, breast-cancer treatment)
  • Hypercalcaemia (>2.5mmol/L) - assessed and excluded at baseline
  • Regular use of sun-beds
  • Having a holiday trip for more than 4 weeks, one month prior to commencing the study or plans for a holiday trip out of the country of residence within the study period.
  • Use of vitamin supplements containing vitamin D (if the prospective participants agrees to stop Vitamin D supplementation to join the study, a wash-out period of 8 weeks prior to commencing the trial would be acceptable).
  • Pregnant or planning a pregnancy during the study period.

研究组 & 干预措施

Placebo UK trial

Placebo Comparator

Placebo and living in the UK

干预措施: Placebo (Dietary Supplement)

Placebo Brazil Trial

Placebo Comparator

Placebo and living in the Brazil

干预措施: Placebo (Dietary Supplement)

Vitamin D Brazil Trial

Active Comparator

Vitamin D supplementation and living in Brazil

干预措施: Vitamin D supplementation (Dietary Supplement)

Vitamin D UK trial

Active Comparator

Vitamin D supplementation and living in the UK

干预措施: Vitamin D supplementation (Dietary Supplement)

结局指标

主要结局

Change from baseline vitamin D status at 12 weeks of vitamin D supplementation

时间窗: baseline and 12 weeks

These will be assessed by measuring serum 25(OH)D (in nmol/L) levels in participants at baseline and 12 weeks

次要结局

  • Analyze the difference regarding time and intensity of sun exposure between Brazilian women living in Brazil and Brazilian women living in the UK.(baseline)
  • Prevalence of inadequate dietary Vitamin D intake in these women(baseline)
  • Baseline prevalence of insufficient/deficient levels of vitamin D in these women.(baseline)
  • Change in the number of participants with insufficient/deficient levels of vitamin D after intervention(baseline and after 12 weeks intervention)
  • Influence of latitude on vitamin D optimal levels.(baseline)
  • Influence of skin pigmentation on vitamin D optimal levels.(baseline)
  • Vitamin D status influence on bone health(baseline)
  • Vitamin D supplementation response dependence on initial vitamin D levels.(baseline and after 12 weeks intervention)
  • Genetic and enzymatic mechanisms underlying the response to vitamin D supplementation(baseline and after 12 weeks intervention)

研究者

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

Marcela Moraes Mendes

PhD Research Fellow

University of Surrey

研究点 (4)

Loading locations...

相似试验