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

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT01892748
• Lead Sponsor: ROSA MARIA RODRIGUES PEREIRA

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-04
• Primary Completion: 2013-08
• Study Completion: 2014-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patients receive placebo in similar capsules of cholecalciferol for 24weeks
Cholecalciferol 50.000IU/week	Cholecalciferol	patients will receive vitamin D3 (50.000 IU/week) for 24weeks

Primary Outcome Measures

Name	Time	Method
The change in Disease Activity Score (SLEDAI)	baseline to week 12 and 24

Secondary Outcome Measures

Name	Time	Method
The change in Fatigue Score	baseline to week 12 and 24
The change in Bone Mineral Parameters	baseline to week 12 and 24

Trial Locations

Locations (1)

University of Sao Paulo - School of Medicine; 🇧🇷 Sao Paulo, Brazil