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

Primary Purpose

Chronic Kidney Disease, Insulin Resistance, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

cholecalciferol (TillVal-D)

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Department of Kidney diseases, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Vitamin D3 1600 IU orally twice daily

Placebo orally twice daily

Outcomes

Primary Outcome Measures

Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp

Secondary Outcome Measures

Change in systolic- and diastolic blood pressure

Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH

Change in insulin secretion assessed by intravenous glucose tolerance test

Change in urinary excretion of albumin (UAE) assessed by 24 hour collection

Full Information

NCT ID

NCT00893451

First Posted

May 5, 2009

Last Updated

June 9, 2011

Sponsor

Sahlgrenska University Hospital, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT00893451

Brief Title

Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease

Acronym

VitaD-CKD1

Official Title

Does Vitamin D3 (Cholecalciferol) Supplementation Change Insulin Resistance in Patients With Chronic Kidney Disease?

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Insulin Resistance, Vitamin D Deficiency

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Vitamin D3 1600 IU orally twice daily

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo orally twice daily

Intervention Type

Drug

Intervention Name(s)

cholecalciferol (TillVal-D)

Other Intervention Name(s)

TillVal-D, cholecalciferol, vitamin D3

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo orally twice daily

Primary Outcome Measure Information:

Title

Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp

Time Frame

at week 26

Secondary Outcome Measure Information:

Title

Change in systolic- and diastolic blood pressure

Time Frame

at week 26

Title

Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH

Time Frame

at week 26

Title

Change in insulin secretion assessed by intravenous glucose tolerance test

Time Frame

at week 26

Title

Change in urinary excretion of albumin (UAE) assessed by 24 hour collection

Time Frame

at week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid R Dezfoolian, MD

Organizational Affiliation

Sahlgrenska University Hospital, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Kidney diseases, Sahlgrenska University Hospital

City

Gothenburg

ZIP/Postal Code

41345

Country

Sweden

12. IPD Sharing Statement

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Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease

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