Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.

Study Overview
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Brief Summary
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The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE). The objective of this study is to evaluate the effect of vitamin D supplementation (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity (clinical and laboratory parameters), fatigue and bone mass.

Detailed Description
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This is a study 24-week, two arm, double blinded randomized clinical trial to evaluate the effects of high-dose vitamin D3 supplementation compared with placebo, on activity disease, fatigue and bone mass. Sixty JoSLE patients will be randomized to receive placebo or vitamin D3 (50.000 IU/week) for 24weeks. The patients return to visits in week 12 and week 24 for evaluation. Study will record clinical history, drugs in use, disease activity, and bone mass parameters.

Official Title
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Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent signed 4 of the 11 modified American College of Rheumatology (ACR) Revised Criteria for the Classification of Systemic Lupus Erythematosus . SLEDAI < 8 at Screening and at Baseline Stable immunosuppressive dose prior to randomization. Body Mass Index < 30 Able to swallow pills at randomization Exclusion Criteria: Refuse of the patient or the legal responsible Use of vitamin D2 or D3 supplementation Significant renal insufficiency Primary hyperparathyroidism (known) History of nephrolithiasis (known) Diabetes mellitus requiring insulin therapy History of vertebral compression fractures (known) Pregnancy Use of bisphosphonates

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecalciferol 50.000IU/week<br>patients will receive vitamin D3 (50.000 IU/week) for 24weeks | Drug: Cholecalciferol<br>* All patients and physicians were blinded to group assignment and treatment allocation. The first group received oral cholecalciferol of 50,000 IU/week and for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo<br>patients receive placebo in similar capsules of cholecalciferol for 24weeks | Drug: Placebo<br>* The second group received identical placebo tablets for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.<br>* Other names: No other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Disease Activity Score (SLEDAI) |  | baseline to week 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Fatigue Score |  | baseline to week 12 and 24 | 
| The change in Bone Mineral Parameters |  | baseline to week 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Lupus, Juvenile, Cholecalciferol, Disease activity, Bone Mass, Fatigue