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Completed

NCT Number: NCT00418587

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

800 IU oral daily

Other names: Vitamin D3

Primary outcomes

  1. Hypercalcuria

    Time frame: Monthly

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2014
First posted
Jan 5, 2007
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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