Vitamin D Supplementation and Muscle Characteristics in Trained Subjects

Not Applicable

Completed

• Conditions: Healthy Subjects, Trained
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3

• Registration Number: NCT02599675
• Lead Sponsor: Inland Norway University of Applied Sciences

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
Vitamin D3	Vitamin D3	Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Upper body maximal dynamic strength	wk0, wk12	Changes in the ability of upper body muscles to exert maximal force during dynamic movements
Muscular endurance	wk0, wk12	Changes in the ability of muscles to perform repeated dynamic contractions at submaximal loads (50% of 1 repetition maximum)
Gene expression in muscle	wk0, wk12	Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes
Vitamin D in blood	wk0, wk12	Changes in levels of 25(OH)D in blood
Steroid hormones in blood	wk0, wk12	Changes in levels of steroid hormones in blood

Trial Locations

Locations (1)

Lillehammer University College; 🇳🇴 Lillehammer, Norway