The investigators plan to conduct randomised, double-blind placebo controlled trial to study effects of calcitriol on progress and activity of glumerulonephritis due to Systemic Lupus Erythematosus. Fifty patients with clinically quiescent Systemic Lupus Erythematosus and biopsy-proven glumerulonephritis will be recruited and randomly assigned to treatment group or control group. Patients in treatment group will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily and Patients in control group will receive placebo similar to intervention 1 oral unit daily for 1 year. Renal function based on the American college of rheumatology renal response criteria, Glomular Filtration Rate, Proteinuria, Systemic Lupus Erythematosus Disease Activity Index and serum inflammatory markers will be monitored.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030912762N1
Registration date:2013-04-20, 1392/01/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-20, 1392/01/31
Registrant information
Name
Banafsheh Ghavidel parsa
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 7268
Email address
ghavidelparsa@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- Chancellorship for Research, Guilan University of Medical Sciences, Iran
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of calcitriol on progress and activity of Lupus nephritis
Public title
Therapeutic effect of vitamin D on renal manifestation of systemic lupus erythematosus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
aged 18-65 years; baseline SLEDAI score <= 4; estimated glomerular filtration rate more than 15 ml/min/1.73m2; proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months; on maintenance dose of prednisolone < 15 mg/day, with or without other immunosuppressive medications; serum calcium level in normal range( 8.5-10.5 mg/dl); history of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month; willingness to give written consent and comply with the study protocol;
Exclusion Criteria:
Pregnancy, lactating or childbearing potential without effective method of birth control; Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication; History of malignancy, including leukemia and lymphoma within the past 2 years; Systemic infection requiring therapy at study entry; Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension; History of drug or alcohol abuse within past 2 years; Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml); Participation in any previous trial on vitamin D analogue; Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks; Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D; On other investigational drugs within last 30 days; History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study; History of non-compliance; Known history of sensitivity or allergy to vitamin D analogs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice- Chancellorship for Research, Guilan University of Medical Sciences, Iran
Street address
Research Deputy Building of Guilan University of Medical Sciences, Emam Khomeini boulevard, Rasht, Iran.
City
Rasht
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
1910354604
Health conditions studied
1
Description of health condition studied
Systemic lupus erythematosus
ICD-10 code
M32.1
ICD-10 code description
Systemic lupus erythematosus with organ or system involvement
Primary outcomes
1
Description
proteinuria
Timepoint
every 2 month
Method of measurement
U/A
2
Description
GFR
Timepoint
every 2 month
Method of measurement
U/A
Secondary outcomes
1
Description
renal function
Timepoint
after 1 year
Method of measurement
based on on the ACR renal response criteria
2
Description
activity of lupus
Timepoint
after 1 year
Method of measurement
SLEDAI
3
Description
serum inflammatory markers
Timepoint
after 1 year
Method of measurement
routin laboratory test
Intervention groups
1
Description
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
Category
Treatment - Drugs
2
Description
Patients will receive placebo similar to intervention 1 oral unit daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Street address
Razi Hospital, Sardargangal St. , Rasht, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellorship for Research, Guilan University of Medical Sciences, Iran
Full name of responsible person
Dr Tabari
Street address
Research Deputy Building of Guilan University of Medical Sciences, Emam Khomeini boulevard, Rasht, Iran.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellorship for Research, Guilan University of Medical Sciences, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Student Research Committee, Guilan University of Medical Sciences, Iran
Full name of responsible person
Alireza Amir Maafi
Position
Medical student/ Minister of Student Research Committe
Other areas of specialty/work
Street address
Student Research Committee Office, Research Deputy Building of Guilan University of Medical Sciences, Emam Khomeini boulevard, Rasht, Iran.
City
Rasht
Postal code
Phone
+98 18 1425 4702
Fax
+98 13 1322 8842
Email
alireza.am427@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences, Iran
Full name of responsible person
Banafsheh Ghavidel Parsa
Position
Asistant professor of Rheumatology
Other areas of specialty/work
Street address
Rheumatology Department, Razi Hospital, Sardargangal St. , Rasht, Iran
City
Rasht
Postal code
Phone
+98 18 1425 4702
Fax
Email
bghavidelparsa@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee. Guilan University of Medical Sciences, Iran
Full name of responsible person
Alireza Amir Maafi
Position
Medical student/Minister of Student Research Committee
Other areas of specialty/work
Street address
Student Research Committee Office, Research Deputy Building of Guilan University of Medical Sciences, Emam Khomeini boulevard, Rasht, Iran.
City
Rasht
Postal code
Phone
00
Fax
Email
alireza.am427@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)