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A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients

NCT01650883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2012-07-26

No results posted yet for this study

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.

Conditions

  • Vitamin D 25 OH Deficiency

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

Cholecalciferol 50,000 IU PO every 10 days for 40 days

DIETARY_SUPPLEMENT

Cholecalciferol 5,000 IU

Cholecalciferol 5,000 IU PO daily for 40 days + 1200 mg Calcium Carbonate PO daily for 40 days.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Julio Gonzalez, MD · University of South Florida College of Medicine

  • John D Carter, MD · University of South Florida Division of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01650883 on ClinicalTrials.gov