Vitamin D DeficiencyPhase 4NCT01633853
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
A Phase 4 study testing Vitamin D2 and 1,25(OH)2 Vit D3 in people with Vitamin D Deficiency, run by Dongliang Zhang, MD at 1 site in China.
Trial summary
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D2 and 1,25(OH)2 Vit D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Sep 2015
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age between 18-75 years.
- Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.
Who cannot join
- Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
- New fracture in last 3 months.
- Active system immunity diseases.
- History of liver failure
- History of intestinal malabsorption or chronic diarrhea
- Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
Show all 18Show fewer
- Primary hyperparathyroidism
- Treatment with cinacalcet or other calcimimetic within the past 6 months
- Anticipated dialysis within 6 months after randomization
- Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
- Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
- Current treatment with vitamin D 50,000 IU
- Using glucocorticoid or immunosuppressive agents.
- Acute renal dysfunction.
- The expected live time is less than 2 years.
- Pregnant or lactating woman.
- Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
Read the detailed description
This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 group. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D2, 1,25(OH)2 Vit D3
- Keywords
- chronic kidney disease mineral and bone disorder, vitamin D2, parathyroid hormone
- Medical subject headings
- Vitamin D Deficiency, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Drug
Also called Vitamin D2 soft capsules
Treatment with Vit D2.
1,25(OH)2 Vit D3Drug
Also called Rocaltrol
Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D2 Treatment | Experimental | Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. Receives: Drug: Vitamin D2 |
| 1,25(OH)2 Vitamin D3 | Active comparator | Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone. Receives: Drug: 1,25(OH)2 Vit D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Blood Levels of Calcium at the 24th Month of Following up.
The blood levels of calcium at the 24th month of following up will be detected.
Measured: 24 months
The Blood Levels of Phosphorus at the 24th Month of Following up.
The blood levels of phosphorus at the 24th month of following up will be detected.
Measured: 24 months
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
Measured: 24 months
Secondary outcomes (2)
The Blood 25(OH)Vitamin D Level.
The levels of blood 25(OH)Vitamin D at the 24th month of following up.
Measured: 24 months
The Incidence Rate of Secondary Hyperparathyroidism.
Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2015
- Study completionSep 2015
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 Vitamin D DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongliang Zhang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Sponsor-investigator, Dongliang Zhang, MD, Capital Medical University
- Investigators
- Dongliang Zhang, Doctor, Principal investigator, Nephrology Department of Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633853
- Sponsor's protocol ID
- 2012-078
- Other IDs
- Z121107001012138, 2011-2002-02
- Status last verified
- Jan 2016
- First submitted
- 29 Jun 2012
- Last updated
- 15 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease
- ClinicalTrials.gov ID
- NCT01633853
- Acronym / sponsor ID
- 2012-078
- Conditions
- Vitamin D Deficiency
- Keywords
- chronic kidney disease mineral and bone disorder, vitamin D2, parathyroid hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Dongliang Zhang, MDUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Jul 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
Detailed description
This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 group. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 Treatment | Experimental | Drug: Vitamin D2Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. |
| 1,25(OH)2 Vitamin D3 | Active comparator | Drug: 1,25(OH)2 Vit D3Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with age between 18-75 years.
- Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.
Key exclusion criteria (18 listed)
- Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
- New fracture in last 3 months.
- Active system immunity diseases.
- History of liver failure
- History of intestinal malabsorption or chronic diarrhea
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 D2Also: Vitamin D2 soft capsulesTreatment with Vit D2. | Drug | Vitamin D2 Treatment |
| 1,25(OH)2 Vit D3Also: RocaltrolTreatment with 1,25(OH)2 Vitamin D3(Rocaltrol). | Drug | 1,25(OH)2 Vitamin D3 |
Primary outcome
The Blood Levels of Calcium at the 24th Month of Following up.
Time frame: 24 months
The blood levels of calcium at the 24th month of following up will be detected.
The Blood Levels of Phosphorus at the 24th Month of Following up.
Time frame: 24 months
The blood levels of phosphorus at the 24th month of following up will be detected.
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
Time frame: 24 months
The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
2 secondary outcomes
The Blood 25(OH)Vitamin D Level.
Time frame: 24 months
The Incidence Rate of Secondary Hyperparathyroidism.
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
Dongliang Zhang, Doctor principal investigator
Nephrology Department of Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D2 and 1,25(OH)2 Vit D3 in people with Vitamin D Deficiency, run by Dongliang Zhang, MD at 1 site in China.
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 18 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 15 Feb 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 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?
The Blood Levels of Calcium at the 24th Month of Following up. (time frame: 24 months). The study lists 3 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 15 Feb 2016.