|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01425775 |
|
Date of registration:
|
18/08/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
April 2010 |
|
Target sample size:
|
248 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01425775 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Egypt
| | | | | | | |
|
Contacts
|
|
Name:
|
Anna Abou-Raya, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Faculty of Medicine, University of Alexandria |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Premenopausal women and males of the same body mass index and ethnicity
Exclusion Criteria:
Patients with:
- other inflammatory disorders,
- hepatic disease
- renal disease
- malignant disease.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Systemic Lupus Erythematosus
|
|
Intervention(s)
|
|
Drug: vitamin D 25(OH)D
|
|
Other: Placebo
|
|
Primary Outcome(s)
|
|
Decrease in SLE disease activity
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
alexmed116618166
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|