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Effects of High-Dose Vitamin D on Hormones, Neuromuscular Function, Cognition, and Body Composition in Athletes

2026年6月8日 更新者:Małgorzata Magdalena Michalczyk、The Jerzy Kukuczka Academy of Physical Education in Katowice

The Effect of High-dose Vitamin D Supplementation on Selected Hormone Concentrations, Neuromuscular Transmission, Athletic Performance, Cognitive Functions, and Body Composition in Athletes.

This study aims to evaluate the effects of high-dose vitamin D3 supplementation on selected physiological, neuromuscular, and cognitive parameters in athletes. At the baseline visit, participants will undergo a series of assessments at the Functional Research Laboratory at AWF Katowice, including a 10 mL venous blood sample collection, body composition analysis (via InBody and DEXA scans), neuromuscular function evaluation using tensiomyography (TMG), and computerized cognitive tests via the Vienna Test System.

Following baseline testing, participants will be randomly assigned to either the vitamin D3 group or the placebo group. The active group will receive a daily dose of 4,000 IU of vitamin D3 (1 capsule with dinner), while the control group will receive an identical placebo. The intervention period will last for 4 or 8 weeks. Upon completion of the supplementation period, all baseline assessments will be repeated to evaluate the post-intervention changes.

研究概览

详细说明

For the first visit, the participant is invited to the Functional Research Laboratory at the Academy of Physical Education (AWF) in Katowice. The visit will be initiated with a blood sample collection (10 mL) from the cubital vein, which will be followed by body mass and body composition measurements. These measurements will be performed using the InBody device (in a standing position, in light clothing or underwear) and a DEXA scan (in a supine position, in light clothing), which is utilized to evaluate bone and fat tissue using a minimal dose of X-ray radiation.

As the next stage, a tensiomyographic (TMG) assessment will be conducted in a supine position and in underwear. Single-use electrodes will be attached to the biceps brachii (long head) of both upper limbs and the gastrocnemius (lateral head) of both lower limbs. A completely non-invasive, very low-voltage and low-intensity electrical current will be emitted by an electrostimulator in order to induce muscle contraction and measure its response speed. This assessment will be performed at rest, without a warm-up, is entirely harmless, and can be repeated.

Subsequently, cognitive function tests will be performed using the computerized Vienna Test System (SCHUHFRIED GmbH, Austria). The first test involves reading color-words and naming colors, while the second test involves reading words in an incongruent color and naming colors with an incongruent meaning. Responses will be provided by pressing one of four buttons on a specialized keyboard (time limit: 2500 ms per trial). Each diagnostic block (60 trials) will be preceded by a practice block (10 trials).

Following the completion of all assessments, the participant will be randomly assigned to one of two groups: the supplemented group (vitamin D3) or the placebo group. The randomization into groups will be carried out using balls placed in a black bag. Depending on the assigned group, and once the 25(OH)D3 level results are obtained by the research team (the next business day), the supplement in an appropriate dose or a placebo product will be allocated. The collection of the products will take place on the 3rd day from the start of the project. The dose of vitamin D3 will be of 4,000 IU/day. If assignment to the placebo group occurs during randomization, a placebo supplement will be provided. The supplements will be consumed 1 capsule in the evening (with dinner). The supplementation period will last for 4 or 8 weeks.

After 4 or 8 weeks of supplementation, the study will be concluded, at which point the participant will be invited to AWF again, where all assessments from stage 1 will be repeated.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Mikołowska 72a
      • Katowice、Mikołowska 72a、波兰、40-065
        • 招聘中
        • The Jerzy Kukuczka Academy of Physical Education in Katowice
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • a minimum of 8 years of training experience,
  • absence of injuries in the 6 months leading up to the assessments,
  • consistent engagement in training sessions a minimum of 5 times per week over the last 6 months.

Exclusion Criteria:

  • vitamin D supplementation within one month prior to the study,
  • use of multivitamin supplements,
  • intestinal disorders.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Vitamin D3 supplemented group
Participants in this arm will receive vitamin D3 supplementation at a total daily dose of 4,000 IU. The supplement will be administered 1 capsule in the evening (with dinner). The intervention period will last for either 4 or 8 weeks.
Vitamin D3 will be administered orally in the form of capsules. Participants will ingest a total daily dose of 4,000 IU, split into two doses: 1 capsule (4,000 IU) in the evening with dinner. The intervention will be carried out daily for a duration of either 4 or 8 weeks. Supplementation compliance will be monitored by the research team through capsule counting during follow-up visits.
安慰剂比较:Placebo supplementation group
Participants in this arm will receive placebo supplementation. The supplement will be administered capsule in the evening (with dinner). The intervention period will last for either 4 or 8 weeks.
An identical placebo will be administered orally in the form of capsule, matching the active vitamin D3 supplement in appearance, size, color, and taste. Participants will ingest 1 placebo capsule in the evening with dinner daily for a duration of either 4 or 8 weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Serum 25-Hydroxyvitamin D Concentration
大体时间:8-weeks

Description: Serum concentration of 25-hydroxyvitamin D [25(OH)D] measured using a validated laboratory method to assess vitamin D status.

Unit of Measure: ng/mL

8-weeks

次要结果测量

结果测量
措施说明
大体时间
Corsi Block-Tapping Test - Block Time
大体时间:8-weeks

Description: Visuospatial working memory assessed using the Corsi Block-Tapping Test. Block Time represents the reaction time required to complete the task.

Unit of Measure: ms

8-weeks
Corsi Block-Tapping Test - Reverse Span Score
大体时间:8-weeks

Description: Visuospatial working memory performance assessed using the reverse recall condition of the Corsi Block-Tapping Test.

Unit of Measure: score

8-weeks
Corsi Block-Tapping Test - Unweighted Block Span
大体时间:8-weeks

Description: Maximum sequence length correctly reproduced during the Corsi Block-Tapping Test.

Unit of Measure: blocks

8-weeks

其他结果措施

结果测量
措施说明
大体时间
Countermovement Jump Height
大体时间:8-weeks

Description: Lower-body explosive power assessed using the Countermovement Jump (CMJ) test.

Unit of Measure: cm

8-weeks
Sprint Performance
大体时间:8-weeks
Description: Sprint performance assessed during a short-distance sprint test. Unit of Measure:s
8-weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年7月1日

初级完成 (实际的)

2025年7月10日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • KB-05/2017
  • Institute of Sport Sciences (其他标识符:The Jerzy Kukuczka Academy of Physical Education in Katowice)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 共享时间框架

Start data- 20.05.2026 End- 31.12.2028

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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