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Vitamin Supplement
Open label for Vitamin D Deficiency (VitD/RNA-seq Trial)
Phase 2
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Awards & highlights
VitD/RNA-seq Trial Summary
This trial is testing whether giving veterans vitamin D3 supplements will help lower stress levels and improve prostate health.
Eligible Conditions
- Stress Reaction
- Vitamin D Deficiency
- Prostate Cancer
VitD/RNA-seq Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in transcriptional profiles after vitamin D supplementation.
Secondary outcome measures
Histopathology changes in the Gleason Score on repeat biopsy findings after vitamin D supplementation
Histopathology changes in the highest percentage of core involvement on repeat biopsy findings after vitamin D supplementation.
Histopathology changes in the number of positive cores on repeat biopsy findings after vitamin D supplementation.
+1 moreVitD/RNA-seq Trial Design
1Treatment groups
Experimental Treatment
Group I: Open labelExperimental Treatment4 Interventions
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation
2019
Completed Phase 2
~40
Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation
2019
Completed Phase 2
~40
Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq
2019
Completed Phase 2
~40
cholecalciferol
2011
Completed Phase 4
~3570
Find a Location
Who is running the clinical trial?
Ralph H. Johnson VA Medical CenterFED
18 Previous Clinical Trials
5,558 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,323 Total Patients Enrolled
1 Trials studying Vitamin D Deficiency
330 Patients Enrolled for Vitamin D Deficiency
MUSC Psychiatry and Behavioral SciencesUNKNOWN
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