Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The change in Disease Activity Score (SLEDAI)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 10 Years to 25 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cholecalciferol 50.000IU/week
patients will receive vitamin D3 (50.000 IU/week) for 24weeks
Intervention: Cholecalciferol (Drug)
Placebo
patients receive placebo in similar capsules of cholecalciferol for 24weeks
Intervention: Placebo (Drug)
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(baseline to week 12 and 24)
- The change in Bone Mineral Parameters(baseline to week 12 and 24)
Investigators
ROSA MARIA RODRIGUES PEREIRA
Associate Professor
University of Sao Paulo