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

May 10, 2016 updated by: ROSA MARIA RODRIGUES PEREIRA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01246-903
        • University of Sao Paulo - School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cholecalciferol 50.000IU/week
patients will receive vitamin D3 (50.000 IU/week) for 24weeks
Drug: Cholecalciferol
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.
Other Names:
  • Vitamin D3
Placebo Comparator: Placebo
patients receive placebo in similar capsules of cholecalciferol for 24weeks
Drug: Placebo
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.
Other Names:
  • No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in Disease Activity Score (SLEDAI)
Time Frame: baseline to week 12 and 24
baseline to week 12 and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in Fatigue Score
Time Frame: baseline to week 12 and 24
baseline to week 12 and 24
The change in Bone Mineral Parameters
Time Frame: baseline to week 12 and 24
baseline to week 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ROSA MARIA RODRIGUES PEREIRA

Investigators

  • Principal Investigator: Rosa MR Pereira, MD PhD, University of Sao Paulo - School of Medicine
  • Study Chair: Glauce L Lima, MD, University of Sao Paulo - School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (Estimate)

July 4, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITD59/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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