Effect of vitamin D replacement in patients with chronic kidney disease

Phase 4

Not yet recruiting

• Conditions: Vitamin D deficient stage 3-5 chronic kidney disease, with and without diabetes and pre dialysis; Renal and Urogenital - Kidney disease; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12611001113943
• Lead Sponsor: Sir Charles Gairdner Hospital Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. ages 18-80 years
2. Vitamin D deficiency (25OHD 15- 75nmol/L)
3. Stage 3-5 CKD, not yet on dialysis (eGFRof < 60mL/min/m2)

Exclusion Criteria

1.Serum Calcium > 2.55mmol/L and/ or Phosphate > 1.80mmol/L
2. Severe Calcium deficiency (<15nmol/L)
3. Liver enzymes (Bilirubin, alanine aminotransferase, GGT) > 3 times upper limit of normal
4. Cardiovascular event or unstable cardiovascular disease in preceding 6 months 6 or NYHA heart failure stage III or IV
5. Significant psychiatric disorder
6. Active infection or inflammation
7. Pregnancy/ planning pregnancy
8. Significant proteinuria (= to > 3g/d)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effects of cholecalciferol at an initial dose of 100,000U then 50,000U monthly, or matched placebo, for 6 months on arterial stiffness in 25OHD deficient stage 3-5 CKD patients. Cardiovascular risk will be assessed at baseline (week 0) and 6 months (week 24) after starting study medication. Measurements with SphygmoCor system will include: <br>1. Augmentation index (Alx) <br>2. Pulse Wave Velocity (PWV)[Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment]

Secondary Outcome Measures

Name	Time	Method
Markers of insulin resistance including HOMA score and waist-hip circumference[Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment];Inflammatory markers including interleukins 6, 12 and 18 and C-reactive protein[Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment];Lipid profile[Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment];Markers of bone metabolism[Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment];Change in kidney function (estimated glomerular filtration rate)[Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment];Change in urine proteinuria (determined by spot urine protein/creatinine ratio)[Measured at baseline (week 0) prior to first dose of cholecalciferol and after 6 months (week 24) treatment]