Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus

Stopped early · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

The primary objective of this study is to evaluate the effects of 18 weeks of high-dose vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune function, glucose homeostasis, and bone metabolism in children with systemic lupus erythematosus (SLE) and serum 25-hydroxyvitamin D \[25(OH)D\] levels ≤20 ng/mL.

Key facts

Study ID

NCT01709474

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

7

Starts

2013-06-01

Expected to finish

2014-07-01

Last updated by the study team

2015-12-17

Who can join

Age: 5 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital, Stanford University — Palo Alto, California, United States
• UCSF School of Medicine — San Francisco, California, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Columbia University — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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