Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease (VitaD-CKD1)
|Chronic Kidney Disease Insulin Resistance Vitamin D Deficiency||Drug: cholecalciferol (TillVal-D) Drug: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Does Vitamin D3 (Cholecalciferol) Supplementation Change Insulin Resistance in Patients With Chronic Kidney Disease?|
- Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp [ Time Frame: at week 26 ]
- Change in systolic- and diastolic blood pressure [ Time Frame: at week 26 ]
- Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH [ Time Frame: at week 26 ]
- Change in insulin secretion assessed by intravenous glucose tolerance test [ Time Frame: at week 26 ]
- Change in urinary excretion of albumin (UAE) assessed by 24 hour collection [ Time Frame: at week 26 ]
|Study Start Date:||September 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Active Comparator: A
Vitamin D3 1600 IU orally twice daily
Drug: cholecalciferol (TillVal-D)
In a randomized, two-way cross-over design participants will take vitamin D3 or placebo twice daily during treatment periods of 10 weeks separated by a washout period of 6 weeks.
Other Name: TillVal-D, cholecalciferol, vitamin D3
Placebo Comparator: B
Placebo orally twice daily
Placebo orally twice daily
Insulin resistance, i.e., reduction in insulin responsiveness with a decrease in glucose uptake in insulin target tissues (muscle and adipose tissue) is common in end-stage renal disease (ESRD), but is also present at earlier stages of renal disease with mild-moderate renal function impairment as well as in microalbuminuria and nephrotic syndrome.
Population-based cross-sectional studies have shown that low levels of vitamin D (25(OH) vitamin D) is associated with impaired glucose tolerance in subjects with normal renal function and that reduced renal function and 25(OH) vitamin D deficiency are independently associated with insulin resistance.
Vitamin D has well-known effects on calcium metabolism and skeletal mineralisation but recent experimental studies suggest that vitamin D in addition reduces several inflammatory mediators that are of importance in the development and progression of renal disease which also associated with insulin resistance such as TNF-α and IL-6.
This is a prospective, single-blind, explorative, randomized, placebo-controlled, single-centre, two-way cross-over study with two treatment periods of 10 weeks separated by a washout period of 6 weeks. Non-diabetic patients with chronic kidney disease (CKD) stage 3 and 4 (GFR 15-60 ml/min/1.73m2) who have low serum 25-OH-vitamin D levels (< 30 ng/mL) and elevated fasting serum insulin levels (>10 IU/L) will be randomized to receive either vitamin D3 (cholecalciferol) 3200U orally (tablets) daily or placebo.
Approximately 24 patients are going to complete the study. A pre-entry wash-out period of 6 weeks is needed for patents already on vitamin D treatment. An in vivo assessment of insulin secretion and insulin sensitivity will be made by insulin-glucose clamp at the end of each treatment period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893451
|Department of Kidney diseases, Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|
|Principal Investigator:||Hamid R Dezfoolian, MD||Sahlgrenska University Hospital, Sweden|