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- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Lillehammer, Noruega
- Lillehammer University College
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 dissolvida em azeite, encapsulada
Outros nomes:
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Comparador de Placebo: Placebo
Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
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Azeite, encapsulado
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Lower body maximal dynamic strength
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Gene expression in muscle
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Training diary
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Trainsome 2015#006
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