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

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00418587

MUSC-GAC734-HR16356

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 3 patient groups

1

Experimental group

Description:

800 IU oral daily dose level

Treatment:

Drug: Cholecalciferol

Drug: Cholecalciferol

Drug: Cholecalciferol

2

Experimental group

Description:

2000 IU oral daily dose level

Treatment:

Drug: Cholecalciferol

Drug: Cholecalciferol

Drug: Cholecalciferol

3

Experimental group

Description:

4000 IU oral daily dose level

Treatment:

Drug: Cholecalciferol

Drug: Cholecalciferol

Drug: Cholecalciferol