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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07641075
Effects of High-Dose Vitamin D on Hormones, Neuromuscular Function, Cognition, and Body Composition in Athletes
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Małgorzata Michalczyk, Profesor
- Número de teléfono: +48535016532
- Correo electrónico: m.michalczyk@awf.katowice.pl
Copia de seguridad de contactos de estudio
- Nombre: Małgorzata Michalczyk, Profesor
- Número de teléfono: 535016532
- Correo electrónico: m.michalczyk@awf.katowice.pl
Ubicaciones de estudio
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Mikołowska 72a
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Katowice, Mikołowska 72a, Polonia, 40-065
- Reclutamiento
- The Jerzy Kukuczka Academy of Physical Education in Katowice
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Contacto:
- Małgorzata Michalczyk
- Número de teléfono: 535016532
- Correo electrónico: m.michalczyk@awf.katowice.pl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum 25-Hydroxyvitamin D Concentration
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Corsi Block-Tapping Test - Block Time
Periodo de tiempo: 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
|
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Corsi Block-Tapping Test - Reverse Span Score
Periodo de tiempo: 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
|
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Corsi Block-Tapping Test - Unweighted Block Span
Periodo de tiempo: 8-weeks
|
Description: Maximum sequence length correctly reproduced during the Corsi Block-Tapping Test. Unit of Measure: blocks |
8-weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Countermovement Jump Height
Periodo de tiempo: 8-weeks
|
Description: Lower-body explosive power assessed using the Countermovement Jump (CMJ) test. Unit of Measure: cm |
8-weeks
|
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Sprint Performance
Periodo de tiempo: 8-weeks
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Description: Sprint performance assessed during a short-distance sprint test.
Unit of Measure:s
|
8-weeks
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KB-05/2017
- Institute of Sport Sciences (Otro identificador: The Jerzy Kukuczka Academy of Physical Education in Katowice)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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