Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus

Exclusion Criteria

• •Any condition or treatment that, in the opinion of the investigator, places the subject at an unacceptable risk as a participant in the trial;
• •Current pharmacologic vitamin D2 or D3 intake \> 800 IU daily or use of calcitriol at any dose over the past four weeks prior to randomization;
• •Cyclophosphamide or IV glucocorticoid exposure within 12 weeks prior to randomization;
• •Any BILAG A or B manifestation with the exception of a BILAG B mucocutaneous manifestation at screening, and excluding the renal BILAG criteria (see rituximab or belimumab criterion, below);
• •Significant renal insufficiency defined as:
• •* Estimated GFR \< 60 mL/min/1.73m\^2 or estimated GFR \< 90 mL/min/1.73m\^2 with a reduction of the GFR by \> 15% from the last measurement;
• •* Urine dipstick value of 2+ or higher for protein, unless this is a stable value from the last measurement or, urine protein-creatinine ratio ≥ 50 mg/mmol unless the value represents an improvement of ≥ 25% from the last measurement.
• •Rituximab or belimumab exposure use within 24 weeks prior to randomization;
• •The following laboratory parameters at the Screening visit:
• •* Platelets \< 50,000; WBC \< 2,500; ANC \< 1,000;
• •* Hemoglobin \< 9 mg/dL;
• •* ALT, AST, bilirubin \> 2x upper limit of normal (ULN);
• •* Hypercalcemia (calcium \> ULN);
• •* Hypercalciuria (urinary calcium/creatinine ratio \> 0.2).
• •Primary hyperparathyroidism (known);
• •History of nephrolithiasis (known);
• •Diabetes mellitus requiring insulin therapy;
• •Medications that interfere with vitamin D absorption;
• •History of vertebral compression fractures (known);
• •Pregnancy (girls ≥ 11 years of age must have a negative urine/serum pregnancy test);
• •A history of non-adherence/non-compliance;
• •Other investigational drug and/or treatment during the four weeks or seven half-lives of the other investigational drug prior to the start of study product dosing (Day 0), whichever is the greater length of time to enrollment;
• •Current diagnosis of cancer or chronic infection such as Hepatitis B, Hepatitis C, or tuberculosis;
• •Treatment with digoxin;
• •Flu (influenza) vaccination within one week prior to randomization.