Vitamin D Supplementation and Muscle Characteristics in Trained Subjects

NCT02599675 | Completed DMC

• 1 other identifier: Trainsome 2015#006
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects, Trained

Keywords

Muscle; Vitamin D; Strength; Endurance; Muscle fiber

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Gene expression in muscle

  wk0, wk12

• Vitamin D in blood

  wk0, wk12

• Steroid hormones in blood

  wk0, wk12

• Muscular endurance

  wk0, wk12

• Upper body maximal dynamic strength

  wk0, wk12

Other Outcomes (3)

• Training diary

  From 1 month prior to study to post test (w12)

• Vitamin D-intake diary

  From 1 month prior to study to post test (w12)

• Sun exposure diary

  From 1 month prior to study to post test (w12)

Study Arms (2)

Vitamin D3

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 dissolved in olive oil, encapsuled

Also known as: cholecalciferol

Vitamin D3

Placebo DIETARY_SUPPLEMENT

Olive oil, encapsuled

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Individuals that have performed strength and / or endurance exercise training at least 3 X week for at least 6 months prior to the study

Sponsors & Collaborators

• Inland Norway University of Applied Sciences: lead
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

Lillehammer University College

Lillehammer, Norway

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Håvard Nygaard, MSc

  Inland Norway University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-03

Locations

NO (1)