Vitamin D Status and Supplementation in Athletes | NCT02008201

Studies
Vitamin D Status and Supplementation in Athletes

NCT02008201

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Dec 15, 2014Estimated

Enrollment

153Actual

Phase

Phase 3

Conditions

Vitamin D Deficiency

Interventions

vitamin D

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Sep 10, 2013

First Submission Date that Met QC Criteria

Dec 5, 2013

First Posted Date

Dec 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2014

Last Update Posted Date

Dec 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D dose 1	Experimental	Vitamin D dose 1	Dietary Supplement: vitamin D
Vitamin D dose 2	Experimental	Vitamin D dose 2	Dietary Supplement: vitamin D
Vitamin D dose 3	Experimental	Vitamin D dose 3	Dietary Supplement: vitamin D
observational	No Intervention	No dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D	Dietary Supplement		Vitamin D dose 1 Vitamin D dose 2 Vitamin D dose 3

Measure	Description	Time Frame
Change in serum 25(OH)D		Every 3 months during one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

athletes
19-60y

Exclusion Criteria:

subjects who take vitamin D supplements

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lisette de Groot, Prof. Dr.	Wageningen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wageningen University		Wageningen			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided