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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01892748
• Other study ID #: VITD59/11
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2013
• Last updated: July 3, 2013
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2013
• Source: University of Sao Paulo
• Contact: Glauce L Lima, MD
• Phone: 5511983262336
• Email: glauceleao[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Cholecalciferol

• Placebo

Locations

Country	Name	City	State
Brazil	University of Sao Paulo - School of Medicine	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
ROSA MARIA RODRIGUES PEREIRA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Disease Activity Score (SLEDAI)		baseline to week 12 and 24	Yes
Secondary	The change in Fatigue Score		baseline to week 12 and 24	Yes
Secondary	The change in Bone Mineral Parameters		baseline to week 12 and 24	Yes