Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
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|ClinicalTrials.gov Identifier: NCT01892748|
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : May 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Cholecalciferol Drug: Placebo||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||February 2014|
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 Name: Vitamin D3
Placebo Comparator: Placebo
patients receive placebo in similar capsules of cholecalciferol for 24weeks
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 Name: No other names
- The change in Disease Activity Score (SLEDAI) [ Time Frame: baseline to week 12 and 24 ]
- The change in Fatigue Score [ Time Frame: baseline to week 12 and 24 ]
- The change in Bone Mineral Parameters [ Time Frame: baseline to week 12 and 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892748
|University of Sao Paulo - School of Medicine|
|Sao Paulo, Brazil, 01246-903|
|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|