- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Małgorzata Michalczyk, Profesor
- Numéro de téléphone: +48535016532
- E-mail: m.michalczyk@awf.katowice.pl
Sauvegarde des contacts de l'étude
- Nom: Małgorzata Michalczyk, Profesor
- Numéro de téléphone: 535016532
- E-mail: m.michalczyk@awf.katowice.pl
Lieux d'étude
-
-
Mikołowska 72a
-
Katowice, Mikołowska 72a, Pologne, 40-065
- Recrutement
- The Jerzy Kukuczka Academy of Physical Education in Katowice
-
Contact:
- Małgorzata Michalczyk
- Numéro de téléphone: 535016532
- E-mail: m.michalczyk@awf.katowice.pl
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur placebo: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum 25-Hydroxyvitamin D Concentration
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Corsi Block-Tapping Test - Block Time
Délai: 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
Délai: 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
Délai: 8-weeks
|
Description: Maximum sequence length correctly reproduced during the Corsi Block-Tapping Test. Unit of Measure: blocks |
8-weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Countermovement Jump Height
Délai: 8-weeks
|
Description: Lower-body explosive power assessed using the Countermovement Jump (CMJ) test. Unit of Measure: cm |
8-weeks
|
|
Sprint Performance
Délai: 8-weeks
|
Description: Sprint performance assessed during a short-distance sprint test.
Unit of Measure:s
|
8-weeks
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KB-05/2017
- Institute of Sport Sciences (Autre identifiant: The Jerzy Kukuczka Academy of Physical Education in Katowice)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .