Vitamin D Supplementation and Muscle Characteristics in Trained Subjects

Inland Norway University of Applied Sciences

Status: Completed

Conditions: Healthy Subjects, Trained

Treatments: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02599675

Trainsome 2015#006

Details and patient eligibility

About

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

Full description

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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71 participants in 2 patient groups, including a placebo group

Vitamin D3

Experimental group

Description:

Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)

Treatment:

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)

Treatment:

Dietary Supplement: Placebo