NCT02008201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2013

Enrollment Period

1.9 years

First QC Date

September 10, 2013

Last Update Submit

December 12, 2014

Conditions

Vitamin D Deficiency

Keywords

dose-response study

Outcome Measures

Primary Outcomes (1)

  • Change in serum 25(OH)D

    Every 3 months during one year

Study Arms (4)

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

vitamin DDIETARY_SUPPLEMENT
Vitamin D dose 1Vitamin D dose 2Vitamin D dose 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • athletes

You may not qualify if:

  • subjects who take vitamin D supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Netherlands

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Lisette de Groot, Prof. Dr.

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

December 11, 2013

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 15, 2014

Record last verified: 2013-12

Locations

NL(1)