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

ROSA MARIA RODRIGUES PEREIRA60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

CholecalciferolDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: FEMALEMin age: 10 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Sao Paulo - School of Medicine

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

The change in Disease Activity Score (SLEDAI)

Time frame: baseline to week 12 and 24

Secondary Outcomes

The change in Fatigue Score

Time frame: baseline to week 12 and 24

The change in Bone Mineral Parameters

Time frame: baseline to week 12 and 24

Data from ClinicalTrials.gov

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