The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- The change in parathyroid hormone level after two-week supplementation.
研究概览
简要总结
A group of runners received vitamin D (10,000 IU - international unit per day) for two weeks. The aim of the intervention was to check the effect of vitamin D supplementation on selected parameters of inflammation and iron metabolism in comparison with the placebo group. Blood was collected before and after supplementation. Next: before, after 25, 50, 75,100 km running and 12 hours after the run. The data were subjected to statistical analysis.
详细描述
Subjects were randomized to two groups: the experimental one, n = 20 and the placebo one, n = 20 with the same age, experience in running and 25(OH)D level. The experimental group received vitamin D3 supplementation (around 10,000 UI/day, i.e., 20 droplets -Vigantol medicament, Merck) and the control group received a placebo (20 droplets of sunflower oil, placed in an identical bottle as vitamin D3) for two weeks before a run. The last vitamin D dose was taken 24 h before the 100 km ultra-marathon. 40 male athletes took part in the 100 km ultra-marathon. Blood was collected before (day 0) and after supplementation (day 14). Next (day 15): before, after 25, 50, 75,100 km running and 12 hours after the run (day 16). The data were subjected to statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Both groups took drops from the same dark bottles, 20 drops per day for two weeks.
入排标准
- 年龄范围
- 28 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •athletes running ultra-marathons
排除标准
- •vitamin D3 supplementation
- •multivitamin and iron supplementation
- •serum 25(OH)D low < 10 ng/mL
- •serum 25(OH)D high > 100 ng/mL
- •haemoglobin < 10 g/dL
- •other (sports injury, tournament)
研究组 & 干预措施
Vitamin D
Vigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3)
干预措施: Cholecalciferol (Drug)
Control
sunflower oil, (20 droplets) two weeks supplementation.
干预措施: placebo (Other)
结局指标
主要结局
The change in parathyroid hormone level after two-week supplementation.
时间窗: Day 0 to day 14
Measured parameter: parathyroid hormone \[pg/ml\].
Observation of changes in creatine kinase level induced by 100 km running.
时间窗: Day "15 - the run" and day "16 - 12 hours after the run"
Measured parameter: creatine kinase \[U/l\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).
The change in vitamin 25(OH)D level after two-week supplementation.
时间窗: Day 0 to day 14
Measured parameter: vitamin 25(OH)D \[ng/ml\].
Observation of changes in inflammatory parameters: C reactive protein - CRP induced by 100 km running.
时间窗: Day "15 - the run" and day "16 - 12 hours after the run"
Measured parameter of inflammatory: CRP\[mg/l\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).
Observation of changes in leucocytes induced by 100 km running.
时间窗: Day "15 - the run" and day "16 - 12 hours after the run"
Measured parameters of inflammatory: leukocytes \[G/l\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).
Observation of changes in inflammatory parameters:interleukin-6 induced by a 100 km run
时间窗: Day "15 - the run" and day "16 - 12 hours after the run"
Measured parameter of inflammatory: interleukin-6 \[pg/ml\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).
次要结局
- Observation of changes in reticulocytes induced by a 100 km run.(Day "15 - the run" and day "16 - 12 hours after the run")
- Observation of changes in erythroferrone level induced by a 100 km run.(Day "15 - the run" and day "16 - 12 hours after the run")
- Observation of changes in hepcidin level induced by 100 km running.(Day "15 - the run" and day "16 - 12 hours after the run")
- Observation of changes in serum iron level induced by 100 km running.(Day "15 - the run" and day "16 - 12 hours after the run")
- Observation of changes in ferritin induced by 100 km running.(Day "15 - the run" and day "16 - 12 hours after the run")
- Observation of changes in hematocrit induced by a 100 km run.(Day "15 - the run" and day "16 - 12 hours after the run")
- Observation of changes in erythrocytes level induced by a 100 km run.(Day "15 - the run" and day "16 - 12 hours after the run")
- Observation of changes in erythropoietin level induced by a 100 km run.(Day "15 - the run" and day "16 - 12 hours after the run")