- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02599675
Vitamin D Supplementation and Muscle Characteristics in Trained Subjects
Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lillehammer, Noruega
- Lillehammer University College
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Vitamin D3
Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)
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Vitamina D3 disuelta en aceite de oliva, encapsulada
Otros nombres:
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Comparador de placebos: Placebo
Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
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Aceite de oliva, encapsulado
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lower body maximal dynamic strength
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gene expression in muscle
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Training diary
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From 1 month prior to study to post test (w12)
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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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- Trainsome 2015#006
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