Chronic Kidney DiseaseVitaD-CKD1NCT00893451
Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease
A study testing cholecalciferol (TillVal-D) in people with Chronic Kidney Disease and Insulin Resistance, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Insulin Resistance, Vitamin D Deficiency
- What is being tested?
- cholecalciferol (TillVal-D)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Kidney diseases, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: Does Vitamin D3 (Cholecalciferol) Supplementation Change Insulin Resistance in Patients With Chronic Kidney Disease?
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.
- Being tested
- cholecalciferol (TillVal-D), Placebo
- 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
- Medical subject headings
- Renal Insufficiency, Chronic, Insulin Resistance, Vitamin D Deficiency, Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (TillVal-D)Drug
Also called TillVal-D, cholecalciferol, vitamin D3
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.
PlaceboDrug
Placebo orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Vitamin D3 1600 IU orally twice daily Receives: Drug: cholecalciferol (TillVal-D) |
| B | Placebo comparator | Placebo orally twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp
Measured: at week 26
Secondary outcomes (4)
Change in systolic- and diastolic blood pressure
Measured: at week 26
Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH
Measured: at week 26
Change in insulin secretion assessed by intravenous glucose tolerance test
Measured: at week 26
Change in urinary excretion of albumin (UAE) assessed by 24 hour collection
Measured: at week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hamid R Dezfoolian, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893451
- Sponsor's protocol ID
- VitaD-CKD1
- Acronym
- VitaD-CKD1
- Status last verified
- Jun 2011
- First submitted
- 5 May 2009
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vitamin D3 (Cholecalciferol) Supplementation Change Insulin Resistance in Patients With Chronic Kidney Disease?
- ClinicalTrials.gov ID
- NCT00893451
- Acronym / sponsor ID
- VitaD-CKD1 / VitaD-CKD1
- Keywords
- renal disease, renal impairment, chronic kidney disease stage 3-4, 25(OH) vitamin D, cholecalciferol, vitamin D deficiency, insulin resistance, insulin-glucose clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: cholecalciferol (TillVal-D)Vitamin D3 1600 IU orally twice daily |
| B | Placebo comparator | Drug: PlaceboPlacebo orally twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferol (TillVal-D)Also: TillVal-D, cholecalciferol, vitamin D3In 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. | Drug | A |
| PlaceboPlacebo orally twice daily | Drug | B |
Primary outcome
Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp
Time frame: at week 26
4 secondary outcomes
Change in systolic- and diastolic blood pressure
Time frame: at week 26
Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH
Time frame: at week 26
Change in insulin secretion assessed by intravenous glucose tolerance test
Time frame: at week 26
Change in urinary excretion of albumin (UAE) assessed by 24 hour collection
Time frame: at week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid R Dezfoolian, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol (TillVal-D) in people with Chronic Kidney Disease and Insulin Resistance, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp (time frame: at week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.