Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01709474
• Date of registration: 16/10/2012
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus
• Scientific title: Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: June 2013
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01709474
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Emily Von Scheven, MD, MAS
• Affiliation: University of California, San Francisco

• Name: Jon M Burnham, MD, MSCE
• Affiliation: University of Pennsylvania

Key inclusion & exclusion 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.



Age minimum: 5 Years
Age maximum: 20 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Vitamin D3 400 IU

Drug: Vitamin D3 6000 IU

Primary Outcome(s)

Change in Average IFN Module Expression Level [Time Frame: Baseline to Week 18]

Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) = Grade 3 [Time Frame: Baseline to 18 Weeks]

Secondary ID(s)

DAIT ALE05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Autoimmunity Centers of Excellence

Results

• Results available: Yes
• Date Posted: 03/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01709474