Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease (VitaD-CKD1)
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|ClinicalTrials.gov Identifier: NCT00893451|
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Insulin Resistance Vitamin D Deficiency||Drug: cholecalciferol (TillVal-D) Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Does Vitamin D3 (Cholecalciferol) Supplementation Change Insulin Resistance in Patients With Chronic Kidney Disease?|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893451
|Department of Kidney diseases, Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|
|Principal Investigator:||Hamid R Dezfoolian, MD||Sahlgrenska University Hospital, Sweden|