- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02599675
Vitamin D Supplementation and Muscle Characteristics in Trained Subjects
Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Lillehammer, Norge
- Lillehammer University College
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Vitamin D3
Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)
|
Vitamin D3 löst i olivolja, inkapslat
Andra namn:
|
|
Placebo-jämförare: Placebo
Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
|
Olivolja, inkapslad
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lower body maximal dynamic strength
Tidsram: wk 0, wk12
|
Changes in the ability of lower body muscles to exert maximal force during a dynamic movement
|
wk 0, wk12
|
|
Muscle fiber composition
Tidsram: wk0, wk12
|
Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling
|
wk0, wk12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gene expression in muscle
Tidsram: wk0, wk12
|
Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes
|
wk0, wk12
|
|
Vitamin D in blood
Tidsram: wk0, wk12
|
Changes in levels of 25(OH)D in blood
|
wk0, wk12
|
|
Steroid hormones in blood
Tidsram: wk0, wk12
|
Changes in levels of steroid hormones in blood
|
wk0, wk12
|
|
Muscular endurance
Tidsram: wk0, wk12
|
Changes in the ability of muscles to perform repeated dynamic contractions at submaximal loads (50% of 1 repetition maximum)
|
wk0, wk12
|
|
Upper body maximal dynamic strength
Tidsram: wk0, wk12
|
Changes in the ability of upper body muscles to exert maximal force during dynamic movements
|
wk0, wk12
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Training diary
Tidsram: From 1 month prior to study to post test (w12)
|
Diary that includes information on type of training, duration and intensity performed
|
From 1 month prior to study to post test (w12)
|
|
Vitamin D-intake diary
Tidsram: From 1 month prior to study to post test (w12)
|
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
|
From 1 month prior to study to post test (w12)
|
|
Sun exposure diary
Tidsram: 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
|
From 1 month prior to study to post test (w12)
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Trainsome 2015#006
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