Effect of vitamin D3 on progression of diabetic nephropathy

• Register: SLCTR
• Last refreshed on: 27 May 2013
• Main ID: SLCTR/2009/008
• Date of registration: 17/07/2009
• Primary sponsor: University of Ruhuna
• Public title: Effect of vitamin D3 on progression of diabetic nephropathy
• Scientific title: Vitamin D3 therapy on the progression of diabetic nephropathy
• Date of first enrolment: 1/6/2009
• Target sample size: 97 per group
• Recruitment status: Recruiting
• URL: http://www.slctr.lk/trial_details.asp?reg_id={3D740B81-9299-44D9-B2F3-7220079A1618}
• Study type: Interventional
• Study design: Randomised placebo controlled double blind study

Countries of recruitment

Sri Lanka

Contacts

• Name: P L G C Liyanage
• Affiliation: Probationary lecturer

• Name: P L G C Liyanage
• Affiliation: Probationary lecturer

Key inclusion & exclusion criteria

Inclusion criteria: • HbA1c less than 8%
• Blood pressure = or less than130/80 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 less than8.4
• 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 less than 30ml / min/ 1.73m2(stage 4 and 5)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Diabetes mellitus

Intervention(s)

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.

Primary Outcome(s)

To determine the effect of concomitant vitamin D3 therapy on albuminuria and renal functions in patients with early diabetic nephropathy

Secondary Outcome(s)

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)

Secondary ID(s)

none

Source(s) of Monetary Support

University Research Grant.