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

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00893451
First received: May 5, 2009
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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 Intervention
Chronic Kidney Disease
Insulin Resistance
Vitamin D Deficiency
Drug: cholecalciferol (TillVal-D)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Does Vitamin D3 (Cholecalciferol) Supplementation Change Insulin Resistance in Patients With Chronic Kidney Disease?

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp [ Time Frame: at week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in systolic- and diastolic blood pressure [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Change in insulin secretion assessed by intravenous glucose tolerance test [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Change in urinary excretion of albumin (UAE) assessed by 24 hour collection [ Time Frame: at week 26 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893451

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

No publications provided

Responsible Party: Hamid Dezfoolian, MD, Dept. of kidney disease, Sahlgrenska University Hospital, Gothenburg, Sweden
ClinicalTrials.gov Identifier: NCT00893451     History of Changes
Other Study ID Numbers: VitaD-CKD1
Study First Received: May 5, 2009
Last Updated: June 9, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Insulin Resistance
Kidney Diseases
Vitamin D Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 24, 2014