- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02599675
Vitamin D Supplementation and Muscle Characteristics in Trained Subjects
Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Vitamin D insufficiency compromises muscle functionality, leading to changes in muscle mass and strength, manifested at the cellular level. While this is increasingly recognized as a problem for individuals with vitamin D deficiency (typically 25(OH)D < 25 nmol/l), there is no general consensus for the remainder of the vitamin D-spectra. This lack of knowledge is probably linked to the variation in protocols of studies that have investigated the physiological role of vitamin D. These variations vary from aspects such as interventional vs observational studies to aspects related to subject characteristics such as age, health and training status. In this project, we will evaluate the effects of 12 weeks of vitamin D supplementation (2000 IU/day) on muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to either a vitamin D (35) or a placebo group (35) in a double-blinded manner. They will be instructed to continue their ordinary modes and frequency of training.
We anticipate baseline vitamin D levels in blood (and hence changes in vitamin D obtained through supplementation), measured as 25(OH)D, to be a major determinant of the efficacy of the intervention. This means that we expect individuals with low baseline levels of 25(OH)D to display more pronounced changes in functional and biological outcome measures than those with high baseline values. Such a scenario could be related to an inability of our protocol to increase blood levels of 25(OH)D in individuals with higher physiological levels of vitamin D (which essentially means that ingestion of vitamin D3 is leveled out or exceeded by elimination of vitamin D derivatives). Alternatively, it may be related to inabilities of tissues to respond to the resulting elevation in vitamin D levels. To study the individual variation in vitamin D responses, data on both functional and biological variables will be divided into quartiles based on baseline 25(OH)D-levels, whereupon comparisons will be made between the low-end and high-end quartile. Individual variation will also be assessed using a mixed model approach.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Lillehammer, Norvège
- Lillehammer University College
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Individuals that have performed strength and / or endurance exercise training at least 3 X week for at least 6 months prior to the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Vitamin D3
Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)
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Vitamine D3 dissoute dans l'huile d'olive, encapsulée
Autres noms:
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Comparateur placebo: Placebo
Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
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Huile d'olive, encapsulée
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Lower body maximal dynamic strength
Délai: wk 0, wk12
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Changes in the ability of lower body muscles to exert maximal force during a dynamic movement
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wk 0, wk12
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Muscle fiber composition
Délai: wk0, wk12
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Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling
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wk0, wk12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Gene expression in muscle
Délai: wk0, wk12
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Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes
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wk0, wk12
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Vitamin D in blood
Délai: wk0, wk12
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Changes in levels of 25(OH)D in blood
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wk0, wk12
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Steroid hormones in blood
Délai: wk0, wk12
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Changes in levels of steroid hormones in blood
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wk0, wk12
|
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Muscular endurance
Délai: wk0, wk12
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Changes in the ability of muscles to perform repeated dynamic contractions at submaximal loads (50% of 1 repetition maximum)
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wk0, wk12
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Upper body maximal dynamic strength
Délai: wk0, wk12
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Changes in the ability of upper body muscles to exert maximal force during dynamic movements
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wk0, wk12
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Training diary
Délai: From 1 month prior to study to post test (w12)
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Diary that includes information on type of training, duration and intensity performed
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From 1 month prior to study to post test (w12)
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Vitamin D-intake diary
Délai: From 1 month prior to study to post test (w12)
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Diary withthat includes information on approximate intake of vitamin D from sources other than the study-specific supplement, including ingestion of fish, seafood and vitamin D-supplement
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From 1 month prior to study to post test (w12)
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Sun exposure diary
Délai: From 1 month prior to study to post test (w12)
|
Diary that includes information on exposure to solarium or sun in countries south of Norway
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From 1 month prior to study to post test (w12)
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
- Trainsome 2015#006
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