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临床试验/NCT02278172
NCT02278172已完成4 期

The Effects of Vitamin D Supplementation on VO2max in Athletes: a Randomised, Double-blind, Placebo-controlled Trial

University of Ulster1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
44
试验地点
1
主要终点
Aerobic fitness (VO2max)

研究概览

简要总结

The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max in athletes.

Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle function, lung function, body composition, immune function and the self-reported incidence of upper respiratory tract infection.

This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to recruit a total of 50 athletes randomised into either a placebo or treatment group for a 12-week intervention.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Athletes whose sport does not primarily consist of an anaerobic component
  • •Apparently healthy
  • •Over the age of 18

排除标准

  • •Resting arterial hypertension
  • •Individuals who are not an athlete at a University/local sports team
  • •Athletes who predominantly utilise anaerobic energy systems
  • •Athletes under the age of 18
  • •Those that have consumed a supplement containing vitamin D (greater than 400IU/day) or iron supplements for up to 30 days prior to starting the study
  • •Those with health conditions identified by the screening questionnaire
  • •Individuals that are on prescribed medication that is known to affect vitamin D metabolism
  • •Those following a vegan diet
  • •Those with a physical disability that would prevent successful completion of the exercise test
  • •Those who have either had a sun holiday in the 4 weeks prior to starting the study
  • •Those planning a sun holiday during the intervention period

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo solution delivered via oral spray once daily for 12-weeks

干预措施: Placebo (Dietary Supplement)

Vitamin D3 3000IU (75μg)

Active Comparator

Treatment solution delivered via oral spray once daily for 12-weeks

干预措施: Vitamin D (Dietary Supplement)

结局指标

主要结局

Aerobic fitness (VO2max)

时间窗: At baseline and at 12-weeks

A medical screening questionnaire will be completed prior to the test. Athletes resting blood pressure will be measured twice to rule out resting hypertension. After a standardised warm-up, starting speed will be 8/km/hr at 1% incline, until 17/km/hr, after which incline will increase by 1% every minute until VO2max is met. A metabolic cart (Metalyzer 3B) will measure the athlete's ventilation (oxygen uptake and carbon dioxide output) throughout the test. The test will be terminated when two of the following criterion are met\*: Respiratory exchange ratio reaches/exceeds 1.15 AND VO2 plateau observed OR Heart rate within 10bpm of age-predicted maximum \* Except when volitional exhaustion occurs Athletes will be asked to refrain from strenuous activity for 24 hours prior to VO2max testing in order to control for last bout effects. Post-exercise lactate concentration (age and gender adjusted) will further-verify that VO2max was attained using a Lactate Pro device.

次要结局

  • Hand grip strength(At baseline and at 12-weeks)
  • Vertical jump height(At baseline and at 12-weeks)
  • Lung function(At baseline and at 12-weeks)
  • Nutrient intake(At baseline only/ at baseline and at 12-weeks)
  • Self-reported upper respiratory illness(Once per week up to week 12)
  • Physical activity levels(At baseline and at 12-weeks)
  • Body composition(At baseline and at 12-weeks)
  • Vitamin D status(At baseline and at 12-weeks)
  • Immune function(At baseline and at 12-weeks)

研究者

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

Dr Pamela Magee

Dr Pamela Magee

University of Ulster

研究点 (1)

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