Vitamin D Supplementation and Muscle Characteristics in Trained Subjects

Study Overview
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Brief Summary
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This study evaluates the effect of vitamin D supplementation on outcomes muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to ingest either vitamin D (35) or placebo (35) in a double-blinded fashion

Detailed Description
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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.

Official Title
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Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects

Conditions
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Healthy Subjects, Trained

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug) | Dietary Supplement: Vitamin D3<br>* Vitamin D3 dissolved in olive oil, encapsuled<br>* Other names: cholecalciferol;|
| Placebo Comparator: Placebo<br>Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group) | Dietary Supplement: Placebo<br>* Olive oil, encapsuled<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower body maximal dynamic strength | Changes in the ability of lower body muscles to exert maximal force during a dynamic movement | wk 0, wk12 | 
| Muscle fiber composition | Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling | wk0, wk12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression in muscle | Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes | wk0, wk12 | 
| Vitamin D in blood | Changes in levels of 25(OH)D in blood | wk0, wk12 | 
| Steroid hormones in blood | Changes in levels of steroid hormones in blood | wk0, wk12 | 
| Muscular endurance | 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 | Changes in the ability of upper body muscles to exert maximal force during dynamic movements | wk0, wk12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle, Vitamin D, Strength, Endurance, Muscle fiber