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临床试验/NCT02599675
NCT02599675已完成不适用

Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects

Inland Norway University of Applied Sciences1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2015年11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
发起方
入组人数
71
试验地点
1
主要终点
Lower body maximal dynamic strength

研究概览

简要总结

This study evaluates the effect of vitamin D supplementation on outcomes muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to ingest either vitamin D (35) or placebo (35) in a double-blinded fashion

详细描述

Vitamin D insufficiency compromises muscle functionality, leading to changes in muscle mass and strength, manifested at the cellular level. While this is increasingly recognized as a problem for individuals with vitamin D deficiency (typically 25(OH)D < 25 nmol/l), there is no general consensus for the remainder of the vitamin D-spectra. This lack of knowledge is probably linked to the variation in protocols of studies that have investigated the physiological role of vitamin D. These variations vary from aspects such as interventional vs observational studies to aspects related to subject characteristics such as age, health and training status. In this project, we will evaluate the effects of 12 weeks of vitamin D supplementation (2000 IU/day) on muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to either a vitamin D (35) or a placebo group (35) in a double-blinded manner. They will be instructed to continue their ordinary modes and frequency of training.

We anticipate baseline vitamin D levels in blood (and hence changes in vitamin D obtained through supplementation), measured as 25(OH)D, to be a major determinant of the efficacy of the intervention. This means that we expect individuals with low baseline levels of 25(OH)D to display more pronounced changes in functional and biological outcome measures than those with high baseline values. Such a scenario could be related to an inability of our protocol to increase blood levels of 25(OH)D in individuals with higher physiological levels of vitamin D (which essentially means that ingestion of vitamin D3 is leveled out or exceeded by elimination of vitamin D derivatives). Alternatively, it may be related to inabilities of tissues to respond to the resulting elevation in vitamin D levels. To study the individual variation in vitamin D responses, data on both functional and biological variables will be divided into quartiles based on baseline 25(OH)D-levels, whereupon comparisons will be made between the low-end and high-end quartile. Individual variation will also be assessed using a mixed model approach.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Individuals that have performed strength and / or endurance exercise training at least 3 X week for at least 6 months prior to the study

排除标准

  • 未提供

研究组 & 干预措施

Vitamin D3

Experimental

Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)

干预措施: Vitamin D3 (Dietary Supplement)

Placebo

Placebo Comparator

Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Lower body maximal dynamic strength

时间窗: wk 0, wk12

Changes in the ability of lower body muscles to exert maximal force during a dynamic movement

Muscle fiber composition

时间窗: wk0, wk12

Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling

次要结局

  • Upper body maximal dynamic strength(wk0, wk12)
  • Muscular endurance(wk0, wk12)
  • Gene expression in muscle(wk0, wk12)
  • Vitamin D in blood(wk0, wk12)
  • Steroid hormones in blood(wk0, wk12)

研究者

发起方
Inland Norway University of Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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