- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02008201
Vitamin D Status and Supplementation in Athletes (D-status)
December 12, 2014 updated by: Wageningen University
Vitamin D Status and Supplementation in Elite Athletes
The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the effect that supplementation may have during the course of a year.
The study is a double blinded parallel study design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines
Study Type
Interventional
Enrollment (Actual)
153
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Wageningen, Netherlands
- Wageningen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- athletes
- 19-60y
Exclusion Criteria:
- subjects who take vitamin D supplements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D dose 1
|
|
Experimental: Vitamin D dose 2
|
|
Experimental: Vitamin D dose 3
|
|
No Intervention: observational
No dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum 25(OH)D
Time Frame: Every 3 months during one year
|
Every 3 months during one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisette de Groot, Prof. Dr., Wageningen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
September 10, 2013
First Submitted That Met QC Criteria
December 5, 2013
First Posted (Estimate)
December 11, 2013
Study Record Updates
Last Update Posted (Estimate)
December 15, 2014
Last Update Submitted That Met QC Criteria
December 12, 2014
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-status
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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