Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

June 14, 2018 updated by: Medical University of South Carolina

Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • SLE by ACR criteria (revised 1997)
  • African American, participating in the SLE in Gullah Health (SLEIGH) Study
  • Outpatient
  • Stable disease with no BILAG A or B in any system for the past 4 weeks
  • Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
  • Baseline 25(OH)D concentration of < 30 ng/ml
  • Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study
  • Age 18 - 85 years
  • Ability to complete questionnaires in English
  • Ability to give informed consent

Exclusion Criteria:

  • Presence of hypercalcemia (>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism
  • Liver disease (serum ALT, AST >2x normal) or total serum bilirubin >1.5x normal
  • History of renal stones
  • Current treatment with any dose of cyclophosphamide
  • Dialysis or creatinine > 2.5 mg/dL
  • Pregnancy
  • Current drug or alcohol abuse
  • Anticipated poor compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
800 IU oral daily dose level
Drug: Cholecalciferol
800 IU oral daily
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
2000 IU oral daily
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
4000 IU oral daily
Other Names:
  • Vitamin D3
EXPERIMENTAL: 2
2000 IU oral daily dose level
Drug: Cholecalciferol
800 IU oral daily
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
2000 IU oral daily
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
4000 IU oral daily
Other Names:
  • Vitamin D3
EXPERIMENTAL: 3
4000 IU oral daily dose level
Drug: Cholecalciferol
800 IU oral daily
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
2000 IU oral daily
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
4000 IU oral daily
Other Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypercalcuria
Time Frame: Monthly
Monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
American College of Rheumatology Research and Education Foundation

Investigators

  • Principal Investigator: Diane L Kamen, MD, MSCR, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (ESTIMATE)

January 5, 2007

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSC-GAC734-HR16356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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