Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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/insufficiency and elevated fasting serum insulin levels.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sahlgrenska University Hospital, Sweden
• Treatments: Cholecalciferol; Ergocalciferols; Insulin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Male or female, age older than 18 years

2. Non-diabetic chronic kidney disease stage 3 and 4 (GFR 15-60 ml/min/1.73 m2)

3. Serum 25(OH) vitamin D < 30 ng/mL (75 nmol/L)

4. Fasting S-insulin > 30 IU/L

5. Written informed consent before entered into study

Exclusion Criteria:

1. 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

2. Patients with type 1 or type 2 Diabetes

3. Current severe thyrotoxicosis or other endocrine disease

4. Granulomatous disease, such as sarcoidosis and tuberculosis

5. Patients who are intended to receive hemodialysis (HD), peritoneal dialysis (PD) or being kidney transplanted during the course of study (9 months)

6. Concomitant use of corticosteroids (except for inhalation or topical use) or other immunosuppressive medication

7. Treatment with biphosphonate during last two years

8. S-Calcium > 2.70 mmol/L (0.68 mg/dl)

9. PTH intact < 75 ng/L (8.25 nmol/L) or > 800 ng/L (88 nmol/L)

10. Proteinuria > 3.5 g/24 hours

11. Alcohol or drug abuse or any condition associated with poor compliance

12. Blood donors

13. Women of childbearing potential, desired pregnancy, pregnancy or lactation within the study period

14. Allergy or intolerance to cholecalciferol supplementation (TillVal D®) or other constituents

15. Participation in a clinical trial evaluating an investigational drug in the last 12 weeks prior to inclusion to this trial

16. History of kidney stones

17. History of chronic hepatitis or liver enzymes (ASAT or ALAT) more than 2.5 times the upper limit of normal

18. Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption

19. Use of medications known to interact with vitamin D metabolism such as cholestyramine, phenytoin, digitalis and antacids

20. Planned vacation with "high sun exposure" during the study period