Vitamin D3 in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00710021
• Date of registration: 01/07/2008
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Vitamin D3 in Systemic Lupus Erythematosus
• Scientific title: Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)
• Date of first enrolment: November 2008
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00710021
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Diane Kamen, MD
• Affiliation: Medical University of South Carolina

• Name: Cynthia Aranow, MD
• Affiliation: The Feinstein Institute for Medical Research

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of SLE by American College of Rheumatology (ACR) criteria

- Serum 25-OH vitamin D level of 20 ng/mL or less

- Stable disease at screening, defined as a modified Safety of Estrogens in Lupus
Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) of 4 or
less

- Interferon (IFN) signature present. More information about this criterion can be found
in the protocol

- Positive anti-double-stranded (anti-ds) DNA antibody blood test at screening

- If on corticosteroids, the dose must be less than 20 mg per day and stable for 4 weeks
prior to screening and at study entry

- If on immunosuppressive or immunomodulatory medication such as azathioprine,
methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must be
stable for 3 months prior to screening and at study entry

- If receiving a multivitamin or a vitamin D supplement, the dose of vitamin D must be
800 IU daily or less and stable for the 3 months prior to screening and at study entry

- Agree to use effective contraceptive methods for the duration of the study

Exclusion Criteria:

- Unwilling to stop using drugs or substances that may interfere with fat absorption

- Hypercalcemia

- Hypercalciuria

- History of hyperparathyroidism

- History of kidney stones

- History of cancer, except cervical carcinoma in situ and resected basal and squamous
cell carcinomas of the skin

- Known history of chronic viral infections, including human immunodeficiency virus
(HIV), Hepatitis B, and Hepatitis C

- Known active tuberculosis

- Any British Isles Lupus Assessment Group (BILAG) A or B manifestation with the
exception of a BILAG B mucocutaneous manifestation

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver function
tests greater than or equal to two times the upper limit of normal

- Dialysis or serum creatinine greater than 1.5 mg/dL

- Expectation by the investigator to increase corticosteroid or immunosuppressive or
immunomodulatory medication dose at screening, study entry, or over the course of the
study

- Treatment with cyclophosphamide within 3 months of screening

- Treatment with rituximab within 12 months of screening

- Other investigational drug and or treatment during the 4 weeks or seven half lives of
the other investigational drug prior to study entry

- Drug or alcohol abuse within 6 months prior to study entry

- Treatment with digoxin

- Treatment with teriparatide

- Any condition that, in the opinion of the investigator, would jeopardize the subject's
safety following exposure to the study drug

- Pregnant or breastfeeding



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

SLE

Lupus

Intervention(s)

Drug: Vitamin D3 placebo

Drug: Vitamin D3

Primary Outcome(s)

Percent of Participants With an IFN Alpha Signature Response at Week 12 [Time Frame: 0, Week 12]

Secondary Outcome(s)

Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12 [Time Frame: 0, Week 12]

Ophthalmic BILAG Status at Week 12 [Time Frame: Week 12]

Change in SELENA-SLEDAI Total Score From Baseline to Week 12 [Time Frame: 0, Week 12]

Change in Serum C3 Level From Baseline to Week 12 [Time Frame: 0, Week 12]

Percent of Participants With Adverse Events of Grade 3 or Above [Time Frame: From start of study treatment through Week 12]

Constitutional BILAG Status at Week 12 [Time Frame: Week 12]

qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6 [Time Frame: 0, Week 6]

qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12 [Time Frame: 0, Week 12]

qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6 [Time Frame: 0, Week 6]

Change in Serum C3 Level From Baseline to Week 6 [Time Frame: 0, Week 6]

Percent of Participants With IFN Alpha Signature at Week 12 [Time Frame: 0, Week 12]

Gastrointestinal BILAG Status at Week 12 [Time Frame: Week 12]

Musculoskeletal BILAG Status at Week 12 [Time Frame: Week 12]

qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6 [Time Frame: 0, Week 6]

Change in Serum C4 Level From Baseline to Week 12 [Time Frame: 0, Week 12]

Change in Serum C4 Level From Baseline to Week 6 [Time Frame: 0, Week 6]

Cardiorespiratory BILAG Status at Week 12 [Time Frame: Week 12]

Percent of Participants With an IFN Alpha Signature Response at Week 6 [Time Frame: 0, Week 6]

qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12 [Time Frame: 0, Week 12]

Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6 [Time Frame: 0, Week 6]

Mucocutaneous BILAG Status at Week 12 [Time Frame: Week 12]

Neuropsychiatric BILAG Status at Week 12 [Time Frame: Week 12]

qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12 [Time Frame: 0, Week 12]

Hematological BILAG Status at Week 12 [Time Frame: Week 12]

Renal BILAG Status at Week 12 [Time Frame: Week 12]

Percent of Participants With IFN Alpha Signature at Week 6 [Time Frame: Week 6]

Secondary ID(s)

DAIT ALE02

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: 25/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00710021