Chronic Kidney DiseaseEVIDENCENCT01672047
Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients
A study testing Vitamin D2 in people with Chronic Kidney Disease and Vitamin D Deficiency, run by Peking University People's Hospital at 1 site in China.
Trial summary
The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Vitamin D Deficiency
- What is being tested?
- Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic kidney disease patients (3-5D)
- serum 25（OH）D < 40nmol/L(16ng/ml)，serum calcium < 2.55mmol/L（10.2mg/dL）；
- willing to sign
- could obey the follow up design
Who cannot join
- allergy to vitamin D
- heart failure (NYHA more than 2 grade)
- pregnant
- malignant tumor
- critical hepatic disease
- taking Vitamin D or analogue in 3 recent months
- taking other clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
Sui Zhun, MD, 86-010-88325507, suizhun@bjmu.edu.cn
Wang Mei, MD, 86-010-88325513, wangmei@163.com
About this study
The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.
Read the detailed description
We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D and the other will not. They will take coronary artery CT test every year(in 2 years).We will compare the coronary calcification progression between the 2 groups.
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency
- Being tested
- Vitamin D2
- Keywords
- The 25(OH) vitamin D level, The 1.25(OH) vitamin D level, The intact PTH level, The calcification score of coronary artery, The microalbuminuria level
- Medical subject headings
- Renal Insufficiency, Chronic, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Drug
Also called Vitmain D2 capsule
25（OH）D level <12 nmol/L 50000IU/weekX12week， 12-39 nmol/L 50000IU/weekX4week then，50000IU/month， 40-75 nmol/L 50000IU/month， 75-116.75nmol/L 25000IU/month， >116.75nmol/L stopped.
| Study group | Role | What they receive |
|---|---|---|
| Treament | Experimental | Intervention Vitamin D2 Receives: Drug: Vitamin D2 |
| Control | No intervention | Not take Vitamin D2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement of coronary artery calcification
We use CT to detect the coronary artery calcification score in the chronic kidney disease patients for 3 times (baseline, 12 month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。
Measured: 2 years
Secondary outcomes (1)
the improvement of proteinuria
We detect the microalbuminuria in the chronic kidney disease patients for 5 times (baseline, 6 month,12 month 18month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2014 (estimated)
- Study completionDec 2015 (estimated)
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 Peking University People's HospitalThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Mei, Peking University People's Hospital
- Investigators
- Mei Wang, MD, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672047
- Sponsor's protocol ID
- PURCP201103
- Acronym
- EVIDENCE
- Status last verified
- Aug 2012
- First submitted
- 21 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients
- ClinicalTrials.gov ID
- NCT01672047
- Acronym / sponsor ID
- EVIDENCE / PURCP201103
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency
- Keywords
- The 25(OH) vitamin D level, The 1.25(OH) vitamin D level, The intact PTH level, The calcification score of coronary artery, The microalbuminuria level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Aug 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.
The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.
Detailed description
We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D and the other will not. They will take coronary artery CT test every year(in 2 years).We will compare the coronary calcification progression between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treament | Experimental | Drug: Vitamin D2Intervention Vitamin D2 |
| Control | No intervention | –Not take Vitamin D2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic kidney disease patients (3-5D)
- serum 25（OH）D < 40nmol/L(16ng/ml)，serum calcium < 2.55mmol/L（10.2mg/dL）；
- willing to sign
- could obey the follow up design
Key exclusion criteria (7 listed)
- allergy to vitamin D
- heart failure (NYHA more than 2 grade)
- pregnant
- malignant tumor
- critical hepatic disease
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: Vitmain D2 capsule25（OH）D level <12 nmol/L 50000IU/weekX12week， 12-39 nmol/L 50000IU/weekX4week then，50000IU/month， 40-75 nmol/L 50000IU/month， 75-116.75nmol/L 25000IU/month， >116.75nmol/L stopped. | Drug | Treament |
Primary outcome
the improvement of coronary artery calcification
Time frame: 2 years
We use CT to detect the coronary artery calcification score in the chronic kidney disease patients for 3 times (baseline, 12 month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。
1 secondary outcome
the improvement of proteinuria
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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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.
Mei Wang, MD, PhD principal investigator
Peking University People's Hospital
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 in people with Chronic Kidney Disease and Vitamin D Deficiency, run by Peking University 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 4 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 30 Aug 2012. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the improvement of coronary artery calcification (time frame: 2 years). 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 30 Aug 2012.