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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2016 |
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Main ID: |
NCT01892748 |
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Date of registration:
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17/06/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
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Scientific title:
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Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus. |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01892748 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Glauce L Lima, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo - School of Medicine |
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Name:
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Rosa MR Pereira, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo - School of Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
10 Years
Age maximum:
25 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Cholecalciferol
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Drug: Placebo
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Primary Outcome(s)
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The change in Disease Activity Score (SLEDAI)
[Time Frame: baseline to week 12 and 24]
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Secondary Outcome(s)
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The change in Bone Mineral Parameters
[Time Frame: baseline to week 12 and 24]
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The change in Fatigue Score
[Time Frame: baseline to week 12 and 24]
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Secondary ID(s)
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VITD59/11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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