Chronic Kidney DiseaseNCT01835691
Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease
A study testing Vitamin D2 (ergocalciferol) and Vitamin D3 (cholecalciferol) in people with Chronic Kidney Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study is to research two questions. First, is vitamin D3 more effective than vitamin D2 in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients? And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral metabolism parameters? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Vitamin D2 (ergocalciferol) and Vitamin D3 (cholecalciferol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2015
- 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
- Age 18 and above
- Chronic kidney disease with an estimated glomerular filtration rate (GFR) between 15-60 ml/min (CKD stage III-IV)
- Vitamin D insufficiency (25-hydroxyvitamin D level < 30 ng/mL) that has not been treated with vitamin D replacement since the acquisition of this level
Who cannot join
- Current treatment with cholestyramine
- Presence of GI disorders such as short bowel, history of gastrectomy, colectomy, gastric bypass, inflammatory bowel disease, celiac disease, disorders of fat absorption, chronic diarrhea.
- Liver cirrhosis
- Known current substance abuse
- Current treatment with immunosuppressant medications
- Presence of chronic infection
- History of chronic inflammatory disease (i.e. - lupus, active rheumatoid arthritis, Crohns disease)
- Currently receiving high-dose vitamin D replacement (avg dose of ≥ 3,000 U per day) or "active" vitamin D analogue (e.g., calcitriol, which is 1,25-dihydroxyvitamin vitamin D).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
This study is to research two questions. First, is vitamin D3 more effective than vitamin D2 in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients? And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral metabolism parameters?
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 various types of health issues. Patients with CKD exhibit an unusually high rate of vitamin D deficiency, which may contribute to some of the poor clinical outcomes in this group.
This study will randomize patients with CKD and low vitamin D levels to two groups; one group will be treated with vitamin D2 (ergocalciferol) and the other group will be treated with vitamin D3 (cholecalciferol). The purpose of this study is to compare the effects of the two different forms of vitamin D specifically in patients chronic kidney disease.
- Conditions
- Chronic Kidney Disease
- Being tested
- Vitamin D2 (ergocalciferol), Vitamin D3 (cholecalciferol)
- Keywords
- Chronic Kidney Disease, Vitamin D, Vitamin D2, Vitamin D3
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2 (ergocalciferol)Dietary supplement
50,000 units once a week for 12 weeks
Vitamin D3 (cholecalciferol)Dietary supplement
50,000 units once a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D2 (ergocalciferol) | Experimental | 50,000 units once a week for 12 weeks Receives: Dietary Supplement: Vitamin D2 (ergocalciferol) |
| Vitamin D3 (cholecalciferol) | Experimental | 50,000 units once a week for 12 weeks Receives: Dietary Supplement: Vitamin D3 (cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)
Measured: Baseline to immediately post-therapy (week 12)
Secondary outcomes (3)
Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL)
Measured: Baseline to immediately post-therapy (week 12), and week 12 to week 18
Change in total serum 25(OH)D (ng/mL)
Measured: week 12 to week 18
Change in serum intact parathyroid hormone (PTH) (pg/mL)
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionJun 2015
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 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 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
- NCT01835691
- Sponsor's protocol ID
- 12861
- Status last verified
- Oct 2017
- First submitted
- 12 Apr 2013
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01835691
- Acronym / sponsor ID
- 12861
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Vitamin D, Vitamin D2, Vitamin D3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Apr 2013 (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.
This study is to research two questions. First, is vitamin D3 more effective than vitamin D2 in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients? And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral metabolism parameters?
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 various types of health issues. Patients with CKD exhibit an unusually high rate of vitamin D deficiency, which may contribute to some of the poor clinical outcomes in this group.
This study will randomize patients with CKD and low vitamin D levels to two groups; one group will be treated with vitamin D2 (ergocalciferol) and the other group will be treated with vitamin D3 (cholecalciferol). The purpose of this study is to compare the effects of the two different forms of vitamin D specifically in patients chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 (ergocalciferol) | Experimental | Dietary Supplement: Vitamin D2 (ergocalciferol)50,000 units once a week for 12 weeks |
| Vitamin D3 (cholecalciferol) | Experimental | Dietary Supplement: Vitamin D3 (cholecalciferol)50,000 units once a week for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and above
- Chronic kidney disease with an estimated glomerular filtration rate (GFR) between 15-60 ml/min (CKD stage III-IV)
- Vitamin D insufficiency (25-hydroxyvitamin D level < 30 ng/mL) that has not been treated with vitamin D replacement since the acquisition of this level
Key exclusion criteria (8 listed)
- Current treatment with cholestyramine
- Presence of GI disorders such as short bowel, history of gastrectomy, colectomy, gastric bypass, inflammatory bowel disease, celiac disease, disorders of fat absorption, chronic diarrhea.
- Liver cirrhosis
- Known current substance abuse
- Current treatment with immunosuppressant medications
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 |
|---|---|---|
| Vitamin D2 (ergocalciferol)50,000 units once a week for 12 weeks | Dietary supplement | Vitamin D2 (ergocalciferol) |
| Vitamin D3 (cholecalciferol)50,000 units once a week for 12 weeks | Dietary supplement | Vitamin D3 (cholecalciferol) |
Primary outcome
Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)
Time frame: Baseline to immediately post-therapy (week 12)
3 secondary outcomes
Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL)
Time frame: Baseline to immediately post-therapy (week 12), and week 12 to week 18
Change in total serum 25(OH)D (ng/mL)
Time frame: week 12 to week 18
Change in serum intact parathyroid hormone (PTH) (pg/mL)
Time frame: Baseline to week 12
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 19 Oct 2017.
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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 Vitamin D2 (ergocalciferol) and Vitamin D3 (cholecalciferol) in people with Chronic Kidney Disease, 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 8 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 19 Oct 2017. 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?
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 total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL) (time frame: Baseline to immediately post-therapy (week 12)). 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 19 Oct 2017.