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Vitamin D3 Repletion

Cholecalciferol 5,000 IU PO daily x 40 days for Vitamin D Deficiency

N/A
Waitlist Available
Led By Julio Gonzalez, MD
Research Sponsored by University of South Florida
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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to determine whether one of two Vitamin D3 (cholecalciferol) oral treatment regimens is superior to the other in normalizing Vitamin 25 OHD serum levels. While these two regimens in the end provide equal total dosing, the two arms differ in frequency and dosing during a 40 day treatment plan. The primary endpoint will be a direct comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a paired T-test. Secondary endpoints include record of adverse events throughout the 40 day study period as well as changes in basic laboratory values including CMP and ionized Calcium. The investigators hypothesize that the Cholecalciferol (Vitamin D3) daily dosing arm of 5000 IU daily will result in more efficient replacement as compared to the 50,000 IU dosing given every 10 days. Our goal will be to achieve a serum Vitamin 25 OH D level of \> 50 mg/dL at day 40. The investigators propose that 75% of the subjects on daily Vitamin D3 will achieve this level and that 35% of the subjects in the every 10 days dosing arm will reach this goal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cholecaliferol 50,000 IU PO Q10 days x 40 daysExperimental Treatment1 Intervention
Patients in this arm receive Cholecalciferol (vitamin D3) via PO route every 10 days for 40 days for a total of 200,000 IU of Vitamin D3. They also receive daily 1200 mg of Calcium Carbonate via PO route daily for 40 days.
Group II: Cholecalciferol 5,000 IU PO daily x 40 daysExperimental Treatment1 Intervention
Patients in this arm receive 5,000 IU of Cholecalciferol (Vitamin D3) via PO route daily for 40 days for a total of 200,000 IU. These patients also receive 1200 mg of daily Calcium Carbonate via PO route for 40 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholecalciferol
2014
Completed Phase 4
~1100
Cholecalciferol 5,000 IU
2009
N/A
~60

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
426 Previous Clinical Trials
191,413 Total Patients Enrolled
Julio Gonzalez, MDPrincipal InvestigatorUniversity of South Florida College of Medicine
John D Carter, MDPrincipal InvestigatorUniversity of South Florida Division of Rheumatology
2 Previous Clinical Trials
74 Total Patients Enrolled
~3 spots leftby Nov 2025