Status:
COMPLETED
Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease
Lead Sponsor:
Sahlgrenska University Hospital
Conditions:
Chronic Kidney Disease
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the impact of vitamin D3 supplementation on the insulin resistance in non-diabetic patients with chronic kidney disease (CKD) stages 3-4, vitamin D deficiency/...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Male or female, age older than 18 years
- Non-diabetic chronic kidney disease stage 3 and 4 (GFR 15-60 ml/min/1.73 m2)
- Serum 25(OH) vitamin D \< 30 ng/mL (75 nmol/L)
- Fasting S-insulin \> 30 IU/L
- Written informed consent before entered into study
Exclusion
- Patients with current significant, major or unstable cardio-cerebrovascular, infection, respiratory, gastrointestinal or other major disease and risks according to the judgment made by the investigator
- Patients with type 1 or type 2 Diabetes
- Current severe thyrotoxicosis or other endocrine disease
- Granulomatous disease, such as sarcoidosis and tuberculosis
- Patients who are intended to receive hemodialysis (HD), peritoneal dialysis (PD) or being kidney transplanted during the course of study (9 months)
- Concomitant use of corticosteroids (except for inhalation or topical use) or other immunosuppressive medication
- Treatment with biphosphonate during last two years
- S-Calcium \> 2.70 mmol/L (0.68 mg/dl)
- PTH intact \< 75 ng/L (8.25 nmol/L) or \> 800 ng/L (88 nmol/L)
- Proteinuria \> 3.5 g/24 hours
- Alcohol or drug abuse or any condition associated with poor compliance
- Blood donors
- Women of childbearing potential, desired pregnancy, pregnancy or lactation within the study period
- Allergy or intolerance to cholecalciferol supplementation (TillVal D®) or other constituents
- Participation in a clinical trial evaluating an investigational drug in the last 12 weeks prior to inclusion to this trial
- History of kidney stones
- History of chronic hepatitis or liver enzymes (ASAT or ALAT) more than 2.5 times the upper limit of normal
- Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption
- Use of medications known to interact with vitamin D metabolism such as cholestyramine, phenytoin, digitalis and antacids
- Planned vacation with "high sun exposure" during the study period
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00893451
Start Date
September 1 2009
End Date
June 1 2011
Last Update
June 10 2011
Active Locations (1)
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1
Department of Kidney diseases, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345