Phase 2
N=57
Vitamin D3 in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus · SLE · Lupus
Bottom Line
View on ClinicalTrials.gov: NCT00710021 ↗Enrolled (actual)
57
Serious AEs
5.6%
Results posted
Apr 2014
Primary outcome: Primary: Percent of Participants With an IFN Alpha Signature Response at Week 12 — 36.8; 23.5; 27.8; 25.7 Percent of participants — p=0.53
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D3 (Drug); Vitamin D3 placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With an IFN Alpha Signature Response at Week 12 |
36.8; 23.5; 27.8; 25.7 | 0.53 |
| SECONDARY Percent of Participants With an IFN Alpha Signature Response at Week 6 |
36.8; 17.6; 5.6; 11.4 | 0.038 sig |
| SECONDARY Percent of Participants With IFN Alpha Signature at Week 12 |
78.9; 94.1; 100.0; 97.1 | 0.047 sig |
| SECONDARY Percent of Participants With IFN Alpha Signature at Week 6 |
84.2; 94.1; 100.0; 97.1 | 0.12 |
| SECONDARY qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12 |
-8.6; -2.9; 5.2; 1.5 | 0.31 |
| SECONDARY qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6 |
-15.5; -11.6; 6.3; -1.4 | 0.019 sig |
| SECONDARY qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12 |
-2.5; -0.3; 2.9; 1.4 | 0.28 |
| SECONDARY qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6 |
-3.9; -4.6; 4.1; 0.3 | 0.050 |
| SECONDARY qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12 |
-1.6; 2.0; 4.8; 3.5 | 0.29 |
| SECONDARY qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6 |
-4.8; 1.4; 0.7; 1.0 | 0.014 sig |
| SECONDARY Change in Serum C3 Level From Baseline to Week 12 |
1.8; 0.7; 2.9; 1.9 | 0.96 |
| SECONDARY Change in Serum C3 Level From Baseline to Week 6 |
3.3; 3.8; 3.7; 3.8 | 0.67 |
| SECONDARY Change in Serum C4 Level From Baseline to Week 12 |
0.2; -0.3; 1.9; .9 | 0.59 |
| SECONDARY Change in Serum C4 Level From Baseline to Week 6 |
0.3; -0.8; 0.4; -0.2 | 0.65 |
| SECONDARY Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12 |
94.1; 100.0; 77.8; 88.2; 0.0; 0.0 | 0.86 |
| SECONDARY Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6 |
94.7; 93.7; 88.9; 91.2; 0.0; 6.3 | 1.0 |
| SECONDARY Change in SELENA-SLEDAI Total Score From Baseline to Week 12 |
0.0; 0.2; 0.2; 0.2 | 0.62 |
| SECONDARY Cardiorespiratory BILAG Status at Week 12 |
0.0; 6.3; 0.0; 2.9 | 1.0 |
| SECONDARY Constitutional BILAG Status at Week 12 |
0.0; 0.0; 0.0; 0.0 | 1.0 |
| SECONDARY Gastrointestinal BILAG Status at Week 12 |
0.0; 0.0; 0.0; 0.0 | 1.0 |
| SECONDARY Hematological BILAG Status at Week 12 |
0.0; 0.0; 0.0; 0.0 | 1.0 |
| SECONDARY Mucocutaneous BILAG Status at Week 12 |
5.6; 12.5; 0.0; 5.9 | 1.0 |
| SECONDARY Musculoskeletal BILAG Status at Week 12 |
5.6; 0.0; 11.1; 5.9 | 1.0 |
| SECONDARY Neuropsychiatric BILAG Status at Week 12 |
0.0; 0.0; 0.0; 0.0 | 1.0 |
| SECONDARY Ophthalmic BILAG Status at Week 12 |
0.0; 0.0; 0.0; 0.0 | 1.0 |
| SECONDARY Renal BILAG Status at Week 12 |
0.0; 0.0; 0.0; 0.0 | 1.0 |
| SECONDARY Percent of Participants With Adverse Events of Grade 3 or Above |
5.3; 23.5; 22.2; 22.9 | 0.10 |
Summary
The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin D deficiency.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00710021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.