Chronic Kidney Disease Stage 1Phase 4NCT01561222
Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
A Phase 4 study testing Calcitriol in people with Chronic Kidney Disease Stage 1 and Chronic Kidney Disease Stage 2, run by Taixing People's Hospital at 1 site in China.
Trial summary
Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2
- What is being tested?
- Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Mar 2016
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of CKD stage 1 and 2
- Age >18 years
- Ability to provide informed consent
Who cannot join
- On vitamin D in past 4 weeks
- Plans to relocate out of Taixing City in the next one year
- Serum phosphate >5.5 mg/dl in past 3 months
- Serum calcium >10.0 mg/dl in past 3 months
- Cancer
- Transplanted organ
- Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Trial locations and contacts
1 site in 1 country.
China1 site
Taixing People's Hospital
Taishing, Jiangsu, 225400
Xu Zhang, bachelor, 008-613-905-266-789, dr.zhangxu@tom.com
About this study
Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.
- Being tested
- Calcitriol, placebo
- Keywords
- calcitrol, Bone mineral density, Osteoprotegin, Vascular calcification
- Medical subject headings
- Renal Insufficiency, Chronic, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called Rocaltrol
0.25 ug per day for one year
placeboDrug
one pill per day
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Calcitriol | Experimental | Not described Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoprotegin level
To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients
Measured: one year
Secondary outcomes (2)
Bone mineral density
To assess the effect of vitamin D supplementation on bone mineral density in patients with CKD stage 1 and 2
Measured: one year
vascular calcification score
To assess the effect of vitamin D supplementation on vascular calcification score through performing lateral abdominal radiography or CT-based techniques in patients with CKD stage 1 and 2
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJul 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 1Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taixing People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhang, Taixing People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561222
- Sponsor's protocol ID
- zhangxu2012
- Status last verified
- Jun 2015
- First submitted
- 19 Mar 2012
- Last updated
- 8 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
- ClinicalTrials.gov ID
- NCT01561222
- Acronym / sponsor ID
- zhangxu2012
- Keywords
- calcitrol, Bone mineral density, Osteoprotegin, Vascular calcification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taixing People's HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 22 Mar 2012 (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 Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| Calcitriol | Experimental | Drug: Calcitriol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of CKD stage 1 and 2
- Age >18 years
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- On vitamin D in past 4 weeks
- Plans to relocate out of Taixing City in the next one year
- Serum phosphate >5.5 mg/dl in past 3 months
- Serum calcium >10.0 mg/dl in past 3 months
- Cancer
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 |
|---|---|---|
| CalcitriolAlso: Rocaltrol0.25 ug per day for one year | Drug | Calcitriol |
| placeboone pill per day | Drug | placebo |
Primary outcome
Osteoprotegin level
Time frame: one year
To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients
2 secondary outcomes
Bone mineral density
Time frame: one year
vascular calcification score
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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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.
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 Calcitriol in people with Chronic Kidney Disease Stage 1 and Chronic Kidney Disease Stage 2, run by Taixing People's Hospital 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Jun 2015. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Zhang, Bachelor (008-613-905-266-789, dr.zhangxu@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoprotegin level (time frame: one year). 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 8 Jun 2015.