Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Change in serum 25-hydroxyvitamin D concentration
研究概览
简要总结
The purpose of this study is to evaluate vitamin D (VD) deficiency in the population of Chilean Antarctica and evaluate the efficacy and safety of VD supplementation to decrease VD deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health risk in the inhabitants of Chilean Antarctica.
详细描述
The present study consists of an initial cross-sectional evaluation of VD status and specific health biomarkers in inhabitants of Chilean Antarctica, followed by a randomized controlled trial evaluating two acceptable approaches of vitamin D supplementation (cholecalciferol 600 IU daily vs. 25000 IU weekly) in Antarctic inhabitants.
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
- None
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •population of all ages living in the Chilean Antarctic territory during at least 3 months.
排除标准
- •acute or chronic renal disease
- •hyper or hypocalcemia
- •osteomalacia or Paget's disease of bone
- •use of VD supplements or fish oil supplements in the past month in doses higher than 400 IU daily
- •treatment for known VD deficiency in the last 6 months
- •UV phototherapy in the past month.
研究组 & 干预措施
Higher weekly vitamin D3
Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica.
干预措施: cholecalciferol (Dietary Supplement)
Standard daily vitamin D3
Cholecalciferol 600 IU daily during one year or exit from Antarctica.
干预措施: cholecalciferol (Dietary Supplement)
结局指标
主要结局
Change in serum 25-hydroxyvitamin D concentration
时间窗: at end of Antarctic residency or 1 year (90-365 days), whichever came first
In Antarctic inhabitants not supplemented with VD that exit Antarctica before start of RCT phase of study.
次要结局
- sleep pattern(at 0, 6, 12 months of Antarctic residency)
- sun exposure(at 0, 6, 12 months of Antarctic residency)
- food intake of VD(at 0, 6, 12 months of Antarctic residency)
- serum biomarkers for bone metabolism(at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first)
- serum high-sensitivity C-reactive protein (hsCRP)(at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first)
- serum cathelicidin (LL-37) concentration(at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first)