NCT01488227

Brief Summary

Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce injuries and illnesses, and improve performance in collegiate swimmers and divers. Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course of the intervention period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_3 healthy

Timeline
Completed

Started Aug 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

November 29, 2011

Last Update Submit

February 22, 2013

Conditions

Healthy

Keywords

Vitamin D status in athletesVitamin D25(OH)Dathletesbody compositioninflammatory markersillnessinjury

Outcome Measures

Primary Outcomes (1)

  • 25(OH)D)

    Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.

    3 measurement periods over 6 months

Secondary Outcomes (5)

  • Inflammatory Cytokines

    Baseline and Enpoint

  • Bone Turnover Markers

    Baseline, Midpoint, Endpoint

  • DXA Body Composition

    Baseline and Endpoint

  • Vitamin D Lifestyle Survey

    Baseline, Midpoint, Endpoint

  • injury and illness incidence

    6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

Vitamin D

Dietary Supplement: Vitamin D

Oil pill

PLACEBO COMPARATOR

Contains vegetable and soybean oil supplied by Nature Made by Pharmavite LLC located in Northridge, CA and is United States Pharmacopeia (USP) certified.

Dietary Supplement: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

4000 IU of Vitamin D daily for 6 months

Also known as: Vitamin D by Nature Made by Pharmavite LLC
Vitamin D
PlaceboDIETARY_SUPPLEMENT

Acts as a control for the Vitamin D intervention

Also known as: Placebo by Nature Made by Pharmavite LLC
Oil pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • University of Kentucky Swimmers and Divers, at least 18 years old.
  • No recent history of Vitamin D supplementation beyond 400IU

You may not qualify if:

  • hormone replacement therapy,
  • high dose Vitamin D supplementation,
  • history of renal disease or kidney stones,
  • organ transplantation,
  • sarcoidosis,
  • parathyroid disease,
  • history of high blood calcium levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Maja Redzic, B.S.

    University of Kentucky

    STUDY DIRECTOR

  • Regina M Lewis, B.S.

    University of Kentucky

    STUDY DIRECTOR

  • David T Thomas, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 8, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

US(1)