Home » Trials » SLCTR/2009/008
Vitamin D3 therapy on the progression of diabetic nephropathy
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SLCTR Registration Number
SLCTR/2009/008
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Vitamin D3 therapy on the progression of diabetic nephropathy
Public Title of Trial
Effect of vitamin D3 on progression of diabetic nephropathy
Disease or Health Condition(s) Studied
Diabetes mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Effect of vitamin D3 on progression of diabetic nephropathy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Those who become eligible will be assigned, randomly, using a computer generated random table, into two groups, therapy versus placebo. Test group will receive monthly dose of 50,000 IU of vitamin D3 intramuscularly and the control group will be given an equal volume of distilled water (0.25 ml). This will be given once a month for six months by a doctor attached to the study. Patients who are participating in the trial and the principal investigator, who is the data collector, will be blinded regarding group assignment.
Inclusion criteria
•HbA1c < 8% • Blood pressure = or <130/80 mm Hg • Confirmed microalbuminuria or macroalbuminuria( >30 mg/24 hours)
Exclusion criteria
•Treatment with vitamin D or its analogues currently or during the last 12 months • Treatment with pharmacological doses of calcium • Serum total Ca > 10 mg/dl or <8.4 • Serum phosphate > 6mg/dl •Jaundice or confirmed liver disease lasting more than three months, currently or in the past • Decompensated congestive heart failure currently • Patients with hyperparathyroidism, hyperthyroidism or any disease leading to abnormalities in vitamin D or calcium metabolism • Fat malabsorption • Current UTI, renal TB or stones • Estimated GFR < 30ml / min/ 1.73m2(stage 4 and 5)
Primary outcome(s)
|
1.
To determine the effect of concomitant vitamin D3 therapy on albuminuria and renal functions in patients with early diabetic nephropathy |
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Secondary outcome(s)
|
1.
1) To determine the prevalence of nephropathy among adult diabetics attending medical clinics in Teaching Hospital, Karapitiya (THK) and study their demographic and disease-related factors. 2) To determine, in a randomized clinical trial involving patients with early diabetic nephropathy, the effect of vitamin D therapy 2.1. on urinary albumin excretion. 2.2. on renal functions, as determined by serum creatinine and estimated GFR. 2.3. on cardiovascular morbidity and cardiovascular risk profile as determined by the Framingham cardiovascular risk score. 2.4. on plasma renin level. 2.5. on bone mineral density. (BMD) |
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Target number/sample size
194 (97 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2009-06-01
Anticipated end date
2011-06-02
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
University Research Grant.
Regulatory approvals
Status
Approved
Date of Approval
2009-03-12
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
P L G C Liyanage
Probationary lecturer
Hunumelladuwawatta, Ginigala, Talpe
773548684
0912222314
gayanicl@yahoo.com
Contact Person for Public Queries
P L G C Liyanage
Probationary lecturer
Hunumelladuwawatta, Ginigala, Talpe
773548684
0912222314
gayanicl@yahoo.com
Primary study sponsor/organization
University of Ruhuna
Faculty of Medicine, University of Ruhuna, Matara
0912222314
0912234801
dean@sltnet.lk
www.ruh.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
