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Vitamin D Status and Supplementation in Athletes (D-status)

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

vitamin D

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring dose-response study

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

athletes
19-60y

Exclusion Criteria:

subjects who take vitamin D supplements

Sites / Locations

Wageningen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Vitamin D dose 1

Vitamin D dose 2

Vitamin D dose 3

observational

Arm Description

Vitamin D dose 1

Vitamin D dose 2

Vitamin D dose 3

No dose

Outcomes

Primary Outcome Measures

Change in serum 25(OH)D

Secondary Outcome Measures

Full Information

NCT ID

NCT02008201

First Posted

September 10, 2013

Last Updated

December 12, 2014

Sponsor

Wageningen University

1. Study Identification

Unique Protocol Identification Number

NCT02008201

Brief Title

Vitamin D Status and Supplementation in Athletes

Acronym

D-status

Official Title

Vitamin D Status and Supplementation in Elite Athletes

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wageningen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

dose-response study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D dose 1

Arm Type

Experimental

Arm Description

Vitamin D dose 1

Arm Title

Vitamin D dose 2

Arm Type

Experimental

Arm Description

Vitamin D dose 2

Arm Title

Vitamin D dose 3

Arm Type

Experimental

Arm Description

Vitamin D dose 3

Arm Title

observational

Arm Type

No Intervention

Arm Description

No dose

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin D

Primary Outcome Measure Information:

Title

Change in serum 25(OH)D

Time Frame

Every 3 months during one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: athletes 19-60y Exclusion Criteria: subjects who take vitamin D supplements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisette de Groot, Prof. Dr.

Organizational Affiliation

Wageningen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wageningen University

City

Wageningen

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Status and Supplementation in Athletes

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