End-Stage Renal DiseasePhase 2NCT01312714
Vitamin D3 Supplementation in Dialysis Patients
A Phase 2 study testing Cholecalciferol in people with End-Stage Renal Disease, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Sep 2012
- Phase
- Phase 2
- 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
- Hemodialysis or peritoneal dialysis > 3 months
Who cannot join
- Hypercalceamia
- Cancer
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Departments of Medical Research and Medicine, Holstebro Hospital
Holstebro, Holstebro, 7500
About this study
Official title: A Randomized, Placebo-Controlled, Double Blind Study Evaluating the Effect of Cholecalciferol on Vasoactive Hormones, Heart Function, Arterial Stiffness, and Blood Pressure in Dialysis Patients.
Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.
- Conditions
- End-Stage Renal Disease
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Hemodialysis, Peritoneal dialysis, Vitamin D Deficiency, blood pressure, arterial stiffness, Heart function, Renin-angiotensin system, Calcium, FGF-23, Brain natriuretic peptide
- Medical subject headings
- Kidney Failure, Chronic, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
3 tablets of 1000 IU daily for 26 weeks
PlaceboDrug
3 tablets of 1000 IU daily for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Active comparator | Not described Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of NT-proBNP
Measured: 26 weeks
Secondary outcomes (14)
Plasma concentration of ionized calcium
Measured: 4 weeks
Plasma concentration of phosphate
Measured: 4 weeks
Plasma concentration of PTH
Measured: 4 weeks
Plasma concentration of 25-hydroxycholecalciferol
Measured: 4 weeks
24-hour blood pressure
Measured: 26 weeks
Plasma renin concentration
Measured: 26 weeks
Plasma concentration of angiotensin II
Measured: 26 weeks
Plasma concentration of aldosterone
Measured: 26 weeks
Arterial stiffness
Measured: 26 weeks
Serum concentration of FGF-23
Measured: 26 weeks
Plasma concentration of AVP
Measured: 26 weeks
Plasma concentration of ANP
Measured: 26 weeks
Plasma concentration of TNF alpha
Measured: 26 weeks
Heart Function
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Erling B Pedersen, M.D., M.Sci., Principal investigator, Departments of Medical Research and Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312714
- Sponsor's protocol ID
- EBP-TL-2011
- Status last verified
- May 2013
- First submitted
- 9 Mar 2011
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mose FH, Vase H, Larsen T, Kancir AS, Kosierkiewic R, Jonczy B, Hansen AB, Oczachowska-Kulik AE, Thomsen IM, Bech JN, Pedersen EB. Cardiovascular effects of cholecalciferol treatment in dialysis patients--a randomized controlled trial. BMC Nephrol. 2014 Mar 24;15:50. doi: 10.1186/1471-2369-15-50.
PubMed 24661355
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double Blind Study Evaluating the Effect of Cholecalciferol on Vasoactive Hormones, Heart Function, Arterial Stiffness, and Blood Pressure in Dialysis Patients.
- ClinicalTrials.gov ID
- NCT01312714
- Acronym / sponsor ID
- EBP-TL-2011
- Conditions
- End-Stage Renal Disease
- Keywords
- Hemodialysis, Peritoneal dialysis, Vitamin D Deficiency, blood pressure, arterial stiffness, Heart function, Renin-angiotensin system, Calcium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Mar 2011 (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.
Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Active comparator | Drug: Cholecalciferol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodialysis or peritoneal dialysis > 3 months
Key exclusion criteria (3 listed)
- Hypercalceamia
- Cancer
- Inability to give informed consent
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D33 tablets of 1000 IU daily for 26 weeks | Drug | Cholecalciferol |
| Placebo3 tablets of 1000 IU daily for 26 weeks | Drug | Placebo |
Primary outcome
Plasma concentration of NT-proBNP
Time frame: 26 weeks
14 secondary outcomes
Plasma concentration of ionized calcium
Time frame: 4 weeks
Plasma concentration of phosphate
Time frame: 4 weeks
Plasma concentration of PTH
Time frame: 4 weeks
Plasma concentration of 25-hydroxycholecalciferol
Time frame: 4 weeks
24-hour blood pressure
Time frame: 26 weeks
Plasma renin concentration
Time frame: 26 weeks
Plasma concentration of angiotensin II
Time frame: 26 weeks
Plasma concentration of aldosterone
Time frame: 26 weeks
Arterial stiffness
Time frame: 26 weeks
Serum concentration of FGF-23
Time frame: 26 weeks
Plasma concentration of AVP
Time frame: 26 weeks
Plasma concentration of ANP
Time frame: 26 weeks
Plasma concentration of TNF alpha
Time frame: 26 weeks
Heart Function
Time frame: 26 weeks
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 29 May 2013.
- Derived from this study: PubMed 24661355Mose FH, Vase H, Larsen T, Kancir AS, Kosierkiewic R, Jonczy B, Hansen AB, Oczachowska-Kulik AE, Thomsen IM, Bech JN, Pedersen EB. Cardiovascular effects of cholecalciferol treatment in dialysis patients--a randomized controlled trial. BMC Nephrol. 2014 Mar 24;15:50. doi: 10.1186/1471-2369-15-50.
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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.
Erling B Pedersen, M.D., M.Sci. principal investigator
Departments of Medical Research and Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with End-Stage Renal Disease, run by Regional Hospital Holstebro at 1 site in Denmark.
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 1 inclusion and 3 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 29 May 2013. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NT-proBNP (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312714, which also lists 1 linked publication.
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 29 May 2013.