Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
Eligibility criteria:
Inclusion Criteria:

Written informed consent signed by the subject or parent/guardian as appropriate; child assent as appropriate;
Before the age of 19, met at least 4 of the 11 modified American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus as updated in 1997;
Date of SLE diagnosis (as described in Inclusion Criterion 2) at least 24 weeks prior to randomization;
Serum 25-hydroxyvitamin D [25(OH)D] < 20 ng/mL at Screening;
SELENA SLEDAI score > 0 and < 8 at Screening and at Baseline;
If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 15 mg/day or ≤0.5 mg/kg/day, whichever is lower, and stable for at least four weeks prior to randomization. Note, if subjects are taking steroids every other day, divide their dose by 2 to evaluate eligibility;

Stable immunosuppressive dose for at least 12 weeks prior to randomization;

--Immunosuppressive medications allowed include mycophenolate (MMF), azathioprine, methotrexate, antimalarial medications (e.g., hydroxychloroquine), cyclosporine A (CsA), tacrolimus, intravenous immune globulin (IVIG), and abatacept.

Body weight > 25 kg;
Able to swallow pills;
Males and females with reproductive potential must agree to practice effective measures of birth control.

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.