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临床试验/NCT07310329
NCT07310329已完成不适用

Effects of High-Dose Vitamin D Supplementation and Physical Exercise on Vitamin D Metabolites in Professional Football Players: A Pilot Study

Wroclaw University of Health and Sport Sciences2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Changes in serum 25(OH)D₃ concentration

研究概览

简要总结

This randomized, single-blind, placebo-controlled pilot study investigated the effects of high-dose vitamin D₃ supplementation and football-specific physical exercise on vitamin D metabolite concentrations in professional male football players. The study aimed to evaluate the acute response of circulating vitamin D metabolites, including 25-(OH)D₃, 24,25-(OH)₂D₃, and 3-epi-25-(OH)D₃, following a single oral dose of 500,000 IU cholecalciferol combined with high-intensity intermittent exercise typical of competitive football.

Twenty professional football players from a Polish top-division club participated in the study. Participants were randomly assigned to either the supplementation group (SGP) receiving 500,000 IU of vitamin D₃ or the placebo group (PGP) receiving an identical volume of placebo oil. The intervention was administered 48 hours prior to an intra-squad game. Blood samples were collected at three time points: baseline (T3), pre-match (T4), and post-match (T5). The primary outcome was the change in serum 25-(OH)D₃ concentration. Secondary outcomes included changes in 24,25-(OH)₂D₃ and 3-epi-25-(OH)D₃ levels, as well as their ratios. The study also assessed whether physical exercise modulates vitamin D metabolism.

The findings demonstrated that high-dose vitamin D₃ supplementation significantly increased serum 25-(OH)D₃ (↑198%) and 3-epi-25-(OH)D₃ (↑444%) levels, while football-specific exercise itself induced moderate increases in vitamin D metabolites. The results suggest that skeletal muscle may play a key role in vitamin D storage and release in response to exercise. The supplementation was well tolerated, with no adverse events observed.

详细描述

This pilot study was designed to explore the combined effects of high-dose vitamin D₃ supplementation and acute physical exercise on vitamin D metabolism in professional football players. The study responds to growing scientific interest in understanding how vitamin D status influences performance, recovery, and muscle function in athletes. While most previous studies have focused on chronic, low-to-moderate supplementation, this trial examined the response to a single, pharmacological dose of cholecalciferol in a controlled experimental setting.

Study Design

The study employed a randomized, single-blind, placebo-controlled, parallel-group design. Participants were randomly assigned to one of two groups:

Supplementation Group (SGP) - received a single oral dose of 500,000 IU vitamin D₃ (Vigantol Oil, P&G Health, Germany);

Placebo Group (PGP) - received an identical amount of placebo (vegetable oil).

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 (Participant)

盲法说明

Single-blind design: participants were unaware of whether they received vitamin D₃ or placebo; the investigator administering supplements was unblinded.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male professional football players aged 18-35 years
  • Actively training and competing in the Polish first football league
  • No vitamin D or calcium supplementation during the previous 3 months
  • No injuries or illnesses affecting participation

排除标准

  • Current musculoskeletal injury or illness
  • Chronic metabolic, endocrine, or renal disorders
  • Use of vitamin D or calcium supplements
  • Refusal or inability to sign informed consent

结局指标

主要结局

Changes in serum 25(OH)D₃ concentration

时间窗: Baseline (before supplementation), 48 hours after supplementation, and immediately after the football match (2 days after supplementation).

Serum concentrations of 25(OH)D₃ will be measured using isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS). The primary outcome assesses the effect of a single high-dose vitamin D₃ supplementation combined with physical exercise on 25(OH)D₃ concentration in professional football players.

Changes in serum 24,25-dihydroxyvitamin D₃ [24,25(OH)₂D₃] concentration

时间窗: Baseline (T3), 48 hours post-supplementation (T4), and post-exercise (T5)

To evaluate the effect of vitamin D₃ supplementation and physical exercise on 24,25(OH)₂D₃ levels using ID-LC-MS/MS.

次要结局

  • Changes in metabolite ratios (25(OH)D₃:24,25(OH)₂D₃ and 25(OH)D₃:3-epi-25(OH)D₃)(Baseline (before supplementation), 48 hours after supplementation, and immediately after the football match (2 days after supplementation).)

研究者

发起方
Wroclaw University of Health and Sport Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Książek

Associate Professor

Wroclaw University of Health and Sport Sciences

研究点 (2)

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