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

ROSA MARIA RODRIGUES PEREIRA

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01892748

VITD59/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 10 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Cholecalciferol 50.000IU/week

Active Comparator group

Description:

patients will receive vitamin D3 (50.000 IU/week) for 24weeks

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Description:

patients receive placebo in similar capsules of cholecalciferol for 24weeks

Treatment:

Drug: Placebo