- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Małgorzata Michalczyk, Profesor
- Telefonnummer: +48535016532
- E-mail: m.michalczyk@awf.katowice.pl
Undersøgelse Kontakt Backup
- Navn: Małgorzata Michalczyk, Profesor
- Telefonnummer: 535016532
- E-mail: m.michalczyk@awf.katowice.pl
Studiesteder
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Mikołowska 72a
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Katowice, Mikołowska 72a, Polen, 40-065
- Rekruttering
- The Jerzy Kukuczka Academy of Physical Education in Katowice
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Kontakt:
- Małgorzata Michalczyk
- Telefonnummer: 535016532
- E-mail: m.michalczyk@awf.katowice.pl
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Placebo komparator: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Serum 25-Hydroxyvitamin D Concentration
Tidsramme: 8-weeks
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Corsi Block-Tapping Test - Block Time
Tidsramme: 8-weeks
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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
Tidsramme: 8-weeks
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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
Tidsramme: 8-weeks
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Description: Maximum sequence length correctly reproduced during the Corsi Block-Tapping Test. Unit of Measure: blocks |
8-weeks
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Countermovement Jump Height
Tidsramme: 8-weeks
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Description: Lower-body explosive power assessed using the Countermovement Jump (CMJ) test. Unit of Measure: cm |
8-weeks
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Sprint Performance
Tidsramme: 8-weeks
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Description: Sprint performance assessed during a short-distance sprint test.
Unit of Measure:s
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8-weeks
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KB-05/2017
- Institute of Sport Sciences (Anden identifikator: The Jerzy Kukuczka Academy of Physical Education in Katowice)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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