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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ROSA MARIA RODRIGUES PEREIRA
• Treatments: Cholecalciferol; Vitamin D; Vitamins

Criteria

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