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Completed

NCT Number: NCT02599675

Vitamin D Supplementation and Muscle Characteristics in Trained Subjects

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lillehammer University College

Lillehammer, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

Vitamin D3 dissolved in olive oil, encapsuled

Other names: cholecalciferol

Placebo

Dietary Supplement

Olive oil, encapsuled

Primary outcomes

  1. Lower body maximal dynamic strength

    Time frame: wk 0, wk12

    Changes in the ability of lower body muscles to exert maximal force during a dynamic movement

  2. Muscle fiber composition

    Time frame: wk0, wk12

    Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling

Secondary outcomes

  1. Gene expression in muscle

    Time frame: wk0, wk12

    Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes

  2. Vitamin D in blood

    Time frame: wk0, wk12

    Changes in levels of 25(OH)D in blood

  3. Steroid hormones in blood

    Time frame: wk0, wk12

    Changes in levels of steroid hormones in blood

  4. Muscular endurance

    Time frame: wk0, wk12

    Changes in the ability of muscles to perform repeated dynamic contractions at submaximal loads (50% of 1 repetition maximum)

  5. Upper body maximal dynamic strength

    Time frame: wk0, wk12

    Changes in the ability of upper body muscles to exert maximal force during dynamic movements

Other outcomes

  1. Training diary

    Time frame: From 1 month prior to study to post test (w12)

    Diary that includes information on type of training, duration and intensity performed

  2. Vitamin D-intake diary

    Time frame: 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

  3. Sun exposure diary

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Inland Norway University of Applied Sciences

Other

Collaborators

  • Sykehuset Innlandet HF

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2015
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.