- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892748
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 01246-903
- University of Sao Paulo - School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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:
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Placebo Comparator: Placebo
patients receive placebo in similar capsules of cholecalciferol for 24weeks
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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:
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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
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baseline to week 12 and 24
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in Fatigue Score
Time Frame: baseline to week 12 and 24
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baseline to week 12 and 24
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The change in Bone Mineral Parameters
Time Frame: baseline to week 12 and 24
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baseline to week 12 and 24
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Collaborators and Investigators
Sponsor
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
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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