InflammationPhase 1NCT02011828
Ergocalciferol Therapy in Calcidiol Deficient, Hemodialysis Patients on Therapeutic Doses of Paricalcitol
A Phase 1 study testing Ergocalciferol in people with Inflammation and Insulin Resistance, run by University of Utah at 1 site in United States.
Trial summary
The objective of this study is to determine the effects of cholecalciferol treatment on inflammation and insulin resistance, in patients on hemodialysis that are previously treated with paricalcitol. Cholecalciferol is produced by the action of sunlight on a cholesterol precursor in the skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Insulin Resistance
- What is being tested?
- Ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jan 2011
- Phase
- Phase 1
- 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
- Non diabetic patients on HD, on stable dose of paricalcitol supplements for at least 3 months with iPTH in target range. Of the 60 patients enrolled in the observational component, those with high CRP (> 3 mg/dl) and calcidiol deficiency (< 15 ng/ml) will be eligible to participate in the interventional study.
- As the median CRP in the HEMO Study was 11 mg/L and > 80% of HD patients are calcidiol deficient [10], most of the screened patients will be eligible. In each year, the first 12 patients who meet the above criteria and consent for the interventional component, a randomized cross-over trial of cholecalciferol 50,000 IU/ week vs. matching placebo will be conducted.
Who cannot join
- Diabetic patients, not on paricalcitol, enrolled in other interventional studies, hospitalized in the past month or treated for an infection in the past month and pregnancy.
- We will conduct a pregnancy test for women in the reproductive age group (18-55 years) during the initial screening process. We will obtain serum β-HCG levels to rule out pregnancy and the test will be paid for by the study. The results will be reviewed by the PI. If β-HCG levels are positive these patients will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the effects of cholecalciferol treatment on inflammation and insulin resistance, in patients on hemodialysis that are previously treated with paricalcitol.
Cholecalciferol is produced by the action of sunlight on a cholesterol precursor in the skin. This compound is then converted to calcidiol (25(OH) D3) in the liver, whereupon calcidiol is converted in the kidney to calcitriol (1,25(OH)2D3), the active form of vitamin D. However, recently it has been shown that deficiency of either calcidiol or calcitriol is associated with inflammation, insulin resistance and increased mortality in the general population. Furthermore, when both calcidiol and calcitriol were deficient, the mortality risk was much higher than the deficiency of either alone. A possible explanation is that some of the non-renal tissues might critically depend on the endogenous conversion of calcidiol to calcitriol and not on circulating levels of calcitriol. Thus, low circulating levels of calcidiol might be associated with tissue level functional calcitriol deficiency despite adequate circulating levels of calcitriol.
Read more
Therefore, the hypothesis is that:
- In non-diabetic hemodialysis (HD) patients treated with therapeutic doses of paricalcitol (an analog of calcitriol), calcidiol deficiency is associated with inflammation and insulin resistance and
- In calcidiol deficient, non-diabetic HD patients with inflammation and treated with therapeutic doses of paricalcitol, cholecalciferol will reverse the calcidiol deficiency and thereby, reduce inflammation and insulin resistance.
Interleulin-6 (IL-6) is thought to play a central role in insulin resistance by down-regulating glucose transporter-4 messenger RNA. Furthermore, IL-6 levels are significantly negatively associated with calcidiol levels, therefore will be measured as the primary outcome.
- Conditions
- Inflammation, Insulin Resistance
- Being tested
- Ergocalciferol, Placebo
- Keywords
- Hemodialysis, paricalcitol
- Medical subject headings
- Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
50,000 IU/week
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol, then Placebo | Experimental | Participants first receive Ergocalciferol 50,000 international units (IU)/week for the first 12 weeks. After a 4 week wash-out period, they then receive matching placebo treatment for 12 weeks. Receives: Drug: Ergocalciferol; Drug: Placebo |
| Placebo, then Ergocalciferol | Experimental | Participants first receive placebo treatment (matching ergocalciferol 50,000 IU/week) for the first 12 weeks. After a 4 week wash-out period, they then receive ergocalciferol 50,000 IU/week treatment for 12 weeks. Receives: Drug: Ergocalciferol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Interleukin-6 (IL-6)
Comparison of IL-6 levels after treatment with ergocalciferol and after treatment with placebo
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinvasan Beddhu, University of Utah
- Investigators
- Srinivasan Beddhu, MD, Principal investigator, University of UtahVidya Raj Krishnamurthy, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011828
- Sponsor's protocol ID
- IRB_00032685
- Status last verified
- Aug 2016
- First submitted
- 13 Jun 2012
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergocalciferol Therapy in Calcidiol Deficient, Hemodialysis Patients on Therapeutic Doses of Paricalcitol
- ClinicalTrials.gov ID
- NCT02011828
- Acronym / sponsor ID
- IRB_00032685
- Conditions
- Inflammation, Insulin Resistance
- Keywords
- Hemodialysis, paricalcitol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Dec 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.
The objective of this study is to determine the effects of cholecalciferol treatment on inflammation and insulin resistance, in patients on hemodialysis that are previously treated with paricalcitol.
Cholecalciferol is produced by the action of sunlight on a cholesterol precursor in the skin. This compound is then converted to calcidiol (25(OH) D3) in the liver, whereupon calcidiol is converted in the kidney to calcitriol (1,25(OH)2D3), the active form of vitamin D. However, recently it has been shown that deficiency of either calcidiol or calcitriol is associated with inflammation, insulin resistance and increased mortality in the general population. Furthermore, when both calcidiol and calcitriol were deficient, the mortality risk was much higher than the deficiency of either alone. A possible explanation is that some of the non-renal tissues might critically depend on the endogenous conversion of calcidiol to calcitriol and not on circulating levels of calcitriol. Thus, low circulating levels of calcidiol might be associated with tissue level functional calcitriol deficiency despite adequate circulating levels of calcitriol.
Therefore, the hypothesis is that:
- In non-diabetic hemodialysis (HD) patients treated with therapeutic doses of paricalcitol (an analog of calcitriol), calcidiol deficiency is associated with inflammation and insulin resistance and
- In calcidiol deficient, non-diabetic HD patients with inflammation and treated with therapeutic doses of paricalcitol, cholecalciferol will reverse the calcidiol deficiency and thereby, reduce inflammation and insulin resistance.
Interleulin-6 (IL-6) is thought to play a central role in insulin resistance by down-regulating glucose transporter-4 messenger RNA. Furthermore, IL-6 levels are significantly negatively associated with calcidiol levels, therefore will be measured as the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol, then Placebo | Experimental | Drug: Ergocalciferol, Drug: PlaceboParticipants first receive Ergocalciferol 50,000 international units (IU)/week for the first 12 weeks. After a 4 week wash-out period, they then receive matching placebo treatment for 12 weeks. |
| Placebo, then Ergocalciferol | Experimental | Drug: Ergocalciferol, Drug: PlaceboParticipants first receive placebo treatment (matching ergocalciferol 50,000 IU/week) for the first 12 weeks. After a 4 week wash-out period, they then receive ergocalciferol 50,000 IU/week treatment 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 (2 listed)
- Non diabetic patients on HD, on stable dose of paricalcitol supplements for at least 3 months with iPTH in target range. Of the 60 patients enrolled in the observational component, those with high CRP (> 3 mg/dl) and calcidiol deficiency (< 15 ng/ml) will be eligible to participate in the interventional study.
- As the median CRP in the HEMO Study was 11 mg/L and > 80% of HD patients are calcidiol deficient [10], most of the screened patients will be eligible. In each year, the first 12 patients who meet the above criteria and consent for the interventional component, a randomized cross-over trial of cholecalciferol 50,000 IU/ week vs. matching placebo will be conducted.
Key exclusion criteria (2 listed)
- Diabetic patients, not on paricalcitol, enrolled in other interventional studies, hospitalized in the past month or treated for an infection in the past month and pregnancy.
- We will conduct a pregnancy test for women in the reproductive age group (18-55 years) during the initial screening process. We will obtain serum β-HCG levels to rule out pregnancy and the test will be paid for by the study. The results will be reviewed by the PI. If β-HCG levels are positive these patients will be withdrawn from the study.
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 |
|---|---|---|
| Ergocalciferol50,000 IU/week | Drug | Ergocalciferol, then Placebo, Placebo, then Ergocalciferol |
| PlaceboPlacebo tablet | Drug | Ergocalciferol, then Placebo, Placebo, then Ergocalciferol |
Primary outcome
Plasma concentration of Interleukin-6 (IL-6)
Time frame: 28 weeks
Comparison of IL-6 levels after treatment with ergocalciferol and after treatment with placebo
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 11 Aug 2016.
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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.
Srinivasan Beddhu, MD principal investigator
University of Utah
Vidya Raj Krishnamurthy, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ergocalciferol in people with Inflammation and Insulin Resistance, run by University of Utah 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 2 inclusion and 2 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 11 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma concentration of Interleukin-6 (IL-6) (time frame: 28 weeks). 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 11 Aug 2016.