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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
ROSA MARIA RODRIGUES PEREIRA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, Juvenile, Cholecalciferol, Disease activity, Bone Mass, Fatigue, Safety

Eligibility Criteria

10 Years - 25 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Sao Paulo - School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol 50.000IU/week

Placebo

Arm Description

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

patients receive placebo in similar capsules of cholecalciferol for 24weeks

Outcomes

Primary Outcome Measures

The change in Disease Activity Score (SLEDAI)

Secondary Outcome Measures

The change in Fatigue Score
The change in Bone Mineral Parameters

Full Information

First Posted
June 17, 2013
Last Updated
May 10, 2016
Sponsor
ROSA MARIA RODRIGUES PEREIRA
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1. Study Identification

Unique Protocol Identification Number
NCT01892748
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ROSA MARIA RODRIGUES PEREIRA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus, Juvenile, Cholecalciferol, Disease activity, Bone Mass, Fatigue, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol 50.000IU/week
Arm Type
Active Comparator
Arm Description
patients will receive vitamin D3 (50.000 IU/week) for 24weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients receive placebo in similar capsules of cholecalciferol for 24weeks
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
All patients and physicians were blinded to group assignment and treatment allocation. The first group received oral cholecalciferol of 50,000 IU/week and for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
No other names
Intervention Description
The second group received identical placebo tablets for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.
Primary Outcome Measure Information:
Title
The change in Disease Activity Score (SLEDAI)
Time Frame
baseline to week 12 and 24
Secondary Outcome Measure Information:
Title
The change in Fatigue Score
Time Frame
baseline to week 12 and 24
Title
The change in Bone Mineral Parameters
Time Frame
baseline to week 12 and 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa MR Pereira, MD PhD
Organizational Affiliation
University of Sao Paulo - School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glauce L Lima, MD
Organizational Affiliation
University of Sao Paulo - School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo - School of Medicine
City
Sao Paulo
ZIP/Postal Code
01246-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29152675
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.
Results Reference
derived
PubMed Identifier
25988278
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.
Results Reference
derived

Learn more about this trial

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

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