Clinical trial NCT02599675: Vitamin D Supplementation and Muscle Characteristics in Trained Subjects
Official title: Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects, Trained
Keywords: Muscle
Vitamin D
Strength
Endurance
Muscle fiber
Lead sponsor: Inland Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
First posted: 2015-11-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Lower body maximal dynamic strength
timeFrame: wk 0, wk12
measure: Muscle fiber composition
timeFrame: wk0, wk12
Secondary outcomes:
measure: Gene expression in muscle
timeFrame: wk0, wk12
measure: Vitamin D in blood
timeFrame: wk0, wk12
measure: Steroid hormones in blood
timeFrame: wk0, wk12
measure: Muscular endurance
timeFrame: wk0, wk12
measure: Upper body maximal dynamic strength
timeFrame: wk0, wk12
Other outcomes:
measure: Training diary
timeFrame: From 1 month prior to study to post test (w12)
measure: Vitamin D-intake diary
timeFrame: From 1 month prior to study to post test (w12)
measure: Sun exposure diary
timeFrame: From 1 month prior to study to post test (w12)
Locations:
city: Lillehammer
country: Norway
facility: Lillehammer University College
Study officials:
affiliation: Inland Norway University of Applied Sciences
name: Håvard Nygaard, MSc
role: PRINCIPAL_INVESTIGATOR
References: