Chronic Kidney Disease (CKD)NCT01222234
Impact of Vitamin D Therapies on Chronic Kidney Disease
A study testing Cholecalciferol - CKD, Calcitriol - CKD and Cholecalciferol - non-CKD in people with Chronic Kidney Disease (CKD) and End-stage Renal Disease (ESRD), run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Chronic Kidney Disease (CKD), End-stage Renal Disease (ESRD)
- What is being tested?
- Cholecalciferol - CKD, Calcitriol - CKD and Cholecalciferol - non-CKD
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease w/GFR<35ml/min
- Nutritional vitamin D deficiency, defined as 25(OH)D < 25ng/ml
- Secondary hyperparathyroidism, PTH>75pg/mL
Who cannot join
- Active infection
- Recent hospitalization for acute illness (within last month)
- Refusal to study participation
- History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)
- Allergy to cholecalciferol or calcitriol
- History of parathyroidectomy
Show all 9Show fewer
- Functional renal transplant within 5 years
- Current treatment with immunosuppressant medications
- Noncompliance with prescribed medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease
This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.
Read the detailed description
Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.
Vitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.
This study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.
There are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.
- Being tested
- Cholecalciferol - CKD, Calcitriol - CKD, Cholecalciferol - non-CKD
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol - CKDDrug
Also called Vitamin D3
Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks
Calcitriol - CKDDevice
Also called 1,25(OH)2D
Calcitriol 0.25 mcg once daily for 8 weeks
Cholecalciferol - non-CKDDrug
Also called Vitamin D3
Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cholecalciferol - CKD | Experimental | Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks. Receives: Drug: Cholecalciferol - CKD |
| Group 2: Calcitriol - CKD | Experimental | Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered calcitriol 0.25mcg daily for 8 weeks. Receives: Device: Calcitriol - CKD |
| Group 3: Cholecalciferol - non-CKD | Experimental | Patients in this arm have low vitamin D levels and normal kidney function. They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks. Receives: Drug: Cholecalciferol - non-CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte Protein Expression
Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression
Measured: 8 weeks of therapy
Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol
Measured: 8 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Stubbs, MD, University of Kansas Medical Center
- Investigators
- Jason Stubbs, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222234
- Sponsor's protocol ID
- 11936
- Status last verified
- Apr 2016
- First submitted
- 13 Oct 2010
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01222234
- Acronym / sponsor ID
- 11936
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.
Detailed description
Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.
Vitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.
This study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.
There are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cholecalciferol - CKD | Experimental | Drug: Cholecalciferol - CKDPatients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks. |
| Group 2: Calcitriol - CKD | Experimental | Device: Calcitriol - CKDPatients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered calcitriol 0.25mcg daily for 8 weeks. |
| Group 3: Cholecalciferol - non-CKD | Experimental | Drug: Cholecalciferol - non-CKDPatients in this arm have low vitamin D levels and normal kidney function. They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic kidney disease w/GFR<35ml/min
- Nutritional vitamin D deficiency, defined as 25(OH)D < 25ng/ml
- Secondary hyperparathyroidism, PTH>75pg/mL
Key exclusion criteria (9 listed)
- Active infection
- Recent hospitalization for acute illness (within last month)
- Refusal to study participation
- History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)
- Allergy to cholecalciferol or calcitriol
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 - CKDAlso: Vitamin D3Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks | Drug | Group 1: Cholecalciferol - CKD |
| Calcitriol - CKDAlso: 1,25(OH)2DCalcitriol 0.25 mcg once daily for 8 weeks | Device | Group 2: Calcitriol - CKD |
| Cholecalciferol - non-CKDAlso: Vitamin D3Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks | Drug | Group 3: Cholecalciferol - non-CKD |
Primary outcome
Monocyte Protein Expression
Time frame: 8 weeks of therapy
Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression
Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol
Time frame: 8 weeks of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jason Stubbs, MD principal investigator
University of Kansas Medical Center
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 - CKD, Calcitriol - CKD and Cholecalciferol - non-CKD in people with Chronic Kidney Disease (CKD) and End-stage Renal Disease (ESRD), run by University of Kansas Medical Center at 1 site in United States.
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 3 inclusion and 9 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 16 May 2016. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Monocyte Protein Expression (time frame: 8 weeks of therapy). The study lists 2 primary outcomes in all. 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 16 May 2016.