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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00418587
• Date of registration: 04/01/2007
• Prospective Registration: No
• Primary sponsor: Medical University of South Carolina
• Public title: Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
• Scientific title: Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: December 2006
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00418587
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Diane L Kamen, MD, MSCR
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Cholecalciferol

Primary Outcome(s)

Hypercalcuria [Time Frame: Monthly]

Secondary ID(s)

MUSC-GAC734-HR16356

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

American College of Rheumatology Research and Education Foundation