Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease (VitaD-CKD1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00893451
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : June 10, 2011
Information provided by:
Sahlgrenska University Hospital, Sweden

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/insufficiency and elevated fasting serum insulin levels.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Insulin Resistance Vitamin D Deficiency Drug: cholecalciferol (TillVal-D) Drug: Placebo Not Applicable

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 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: Placebo
Placebo orally twice daily

Primary Outcome Measures :
  1. Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp [ Time Frame: at week 26 ]

Secondary Outcome Measures :
  1. Change in systolic- and diastolic blood pressure [ Time Frame: at week 26 ]
  2. Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH [ Time Frame: at week 26 ]
  3. Change in insulin secretion assessed by intravenous glucose tolerance test [ Time Frame: at week 26 ]
  4. Change in urinary excretion of albumin (UAE) assessed by 24 hour collection [ Time Frame: at week 26 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00893451

Department of Kidney diseases, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Principal Investigator: Hamid R Dezfoolian, MD Sahlgrenska University Hospital, Sweden

Responsible Party: Hamid Dezfoolian, MD, Dept. of kidney disease, Sahlgrenska University Hospital, Gothenburg, Sweden Identifier: NCT00893451     History of Changes
Other Study ID Numbers: VitaD-CKD1
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Sahlgrenska University Hospital, Sweden:
renal disease
renal impairment
chronic kidney disease stage 3-4
25(OH) vitamin D
vitamin D deficiency
insulin resistance
insulin-glucose clamp

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Insulin Resistance
Vitamin D Deficiency
Urologic Diseases
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Hypoglycemic Agents
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents