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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cholecalciferol

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Vitamin D, Lupus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

800 IU oral daily dose level

2000 IU oral daily dose level

4000 IU oral daily dose level

Outcomes

Primary Outcome Measures

Hypercalcuria

Secondary Outcome Measures

Full Information

NCT ID

NCT00418587

First Posted

January 4, 2007

Last Updated

June 14, 2018

Sponsor

Medical University of South Carolina

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00418587

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Vitamin D, Lupus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (false)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

800 IU oral daily dose level

Arm Title

Arm Type

Experimental

Arm Description

2000 IU oral daily dose level

Arm Title

Arm Type

Experimental

Arm Description

4000 IU oral daily dose level

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Vitamin D3

Intervention Description

800 IU oral daily

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Vitamin D3

Intervention Description

2000 IU oral daily

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Vitamin D3

Intervention Description

4000 IU oral daily

Primary Outcome Measure Information:

Title

Hypercalcuria

Time Frame

Monthly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diane L Kamen, MD, MSCR

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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

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