The Effects of Vitamin D Supplementation on Aerobic Fitness in Athletes

NCT ID: NCT02278172

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max in athletes.

Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle function, lung function, body composition, immune function and the self-reported incidence of upper respiratory tract infection.

This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to recruit a total of 50 athletes randomised into either a placebo or treatment group for a 12-week intervention.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aerobic Fitness (VO2max)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D3 3000IU (75μg)

Treatment solution delivered via oral spray once daily for 12-weeks

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

3000IU (75 μg) vitamin D in a commercially available oral spray solution

Placebo

Placebo solution delivered via oral spray once daily for 12-weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo oral spray solution manufactured to mimic the vitamin D oral spray

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

3000IU (75 μg) vitamin D in a commercially available oral spray solution

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo oral spray solution manufactured to mimic the vitamin D oral spray

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cholecalciferol vitamin D3

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Athletes whose sport does not primarily consist of an anaerobic component
* Apparently healthy
* Over the age of 18

Exclusion Criteria

* Resting arterial hypertension
* Individuals who are not an athlete at a University/local sports team
* Athletes who predominantly utilise anaerobic energy systems
* Athletes under the age of 18
* Those that have consumed a supplement containing vitamin D (greater than 400IU/day) or iron supplements for up to 30 days prior to starting the study
* Those with health conditions identified by the screening questionnaire
* Individuals that are on prescribed medication that is known to affect vitamin D metabolism
* Those following a vegan diet
* Those with a physical disability that would prevent successful completion of the exercise test
* Those who have either had a sun holiday in the 4 weeks prior to starting the study
* Those planning a sun holiday during the intervention period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northern Ireland Executive

UNKNOWN

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Pamela Magee

Dr Pamela Magee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pamela J Magee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ulster

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Human Intervention Studies Unit (HISU), University of Ulster

Coleraine, Londonderry, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC14.0087

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.