Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00893451
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00893451
Study Brief:
Protocol Section:
NCT00893451