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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
Sponsor:
Information provided by (Responsible Party):
ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Cholecalciferol Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 Name: 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 Name: No other names




Primary Outcome Measures :
  1. The change in Disease Activity Score (SLEDAI) [ Time Frame: baseline to week 12 and 24 ]

Secondary Outcome Measures :
  1. The change in Fatigue Score [ Time Frame: baseline to week 12 and 24 ]
  2. The change in Bone Mineral Parameters [ Time Frame: baseline to week 12 and 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Brazil
University of Sao Paulo - School of Medicine
Sao Paulo, Brazil, 01246-903
Sponsors and Collaborators
ROSA MARIA RODRIGUES PEREIRA
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ROSA MARIA RODRIGUES PEREIRA, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01892748     History of Changes
Other Study ID Numbers: VITD59/11
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo:
Lupus
Juvenile
Cholecalciferol
Disease activity
Bone Mass
Fatigue
Safety
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Fatigue
Signs and Symptoms
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents