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CompletedNCT00893451VitaD-CKD1Updated Jun 10, 2011

Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease

An interventional study of cholecalciferol (TillVal-D) and Placebo in Chronic Kidney Disease, Insulin Resistance and Vitamin D Deficiency, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-10.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 24 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.

Browse Sahlgrenska University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    A

    Vitamin D3 1600 IU orally twice daily

    Drug: cholecalciferol (TillVal-D)

  • Placebo comparator
    B

    Placebo orally twice daily

    Drug: Placebo

Interventions

  • Drugcholecalciferol (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.

    Also known as: TillVal-D, cholecalciferol, vitamin D3

  • DrugPlacebo

    Placebo orally twice daily

06

What researchers measure

Primary outcomes

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

    Time frame: at week 26

Secondary outcomes

  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

07

Study locations

1 site
  • Department of Kidney diseases, Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2009
First posted
May 6, 2009
Start
Sep 2009
Primary completionActual
Jun 2011
CompletionActual
Jun 2011
Last update
Jun 10, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00893451
Lead sponsor
Sahlgrenska University Hospital
First posted
May 6, 2009
Start date
Sep 2009
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jun 10, 2011

Study contacts

Hamid R Dezfoolian, MD
principal investigator · Sahlgrenska University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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