Clinical trial NCT01892748: Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
Official title: Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Juvenile
Cholecalciferol
Disease activity
Bone Mass
Fatigue
Safety
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The change in Disease Activity Score (SLEDAI)
timeFrame: baseline to week 12 and 24
Secondary outcomes:
measure: The change in Fatigue Score
timeFrame: baseline to week 12 and 24
measure: The change in Bone Mineral Parameters
timeFrame: baseline to week 12 and 24
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - School of Medicine
Study officials:
affiliation: University of Sao Paulo - School of Medicine
name: Rosa MR Pereira, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo - School of Medicine
name: Glauce L Lima, MD
role: STUDY_CHAIR
References:
citation: Lima GL, Paupitz JA, Aikawa NE, Alvarenga JC, Pereira RMR. A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. Osteoporos Int. 2018 Mar;29(3):587-594. doi: 10.1007/s00198-017-4316-5. Epub 2017 Nov 19.
citation: Lima GL, Paupitz J, Aikawa NE, Takayama L, Bonfa E, Pereira RM. Vitamin D Supplementation in Adolescents and Young Adults With Juvenile Systemic Lupus Erythematosus for Improvement in Disease Activity and Fatigue Scores: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2016 Jan;68(1):91-8. doi: 10.1002/acr.22621.