Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients (EVIDENCE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Peking University People's Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Peking University People's Hospital
Information provided by (Responsible Party):
Wang Mei, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01672047
First received: August 21, 2012
Last updated: August 29, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease Vitamin D Deficiency |
Drug: Vitamin D2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients |
Resource links provided by NLM:
Further study details as provided by Peking University People's Hospital:
Primary Outcome Measures:
- the improvement of coronary artery calcification [ Time Frame: 2 years ] [ Designated as safety issue: No ]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。
Secondary Outcome Measures:
- the improvement of proteinuria [ Time Frame: 2 years ] [ Designated as safety issue: No ]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。
| Estimated Enrollment: | 350 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treament
Intervention Vitamin D2
|
Drug: Vitamin D2
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. Other Name: Vitmain D2 capsule
|
|
No Intervention: Control
Not take Vitamin D2
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01672047
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672047
Locations
| China, Beijing | |
| The People's Hospital of Peking University | Recruiting |
| Beijing, Beijing, China, 100044 | |
| Contact: Sui Zhun, MD 86-010-88325507 suizhun@bjmu.edu.cn | |
| Contact: Wang Mei, MD 86-010-88325513 wangmei@163.com | |
| Principal Investigator: Wang Mei, MD | |
Sponsors and Collaborators
Peking University People's Hospital
Investigators
| Principal Investigator: | Mei Wang, MD, PhD | Peking University People's Hospital |
More Information
| Responsible Party: | Wang Mei, Professor, Peking University People's Hospital |
| ClinicalTrials.gov Identifier: | NCT01672047 History of Changes |
| Other Study ID Numbers: | PURCP201103 |
| Study First Received: | August 21, 2012 |
| Last Updated: | August 29, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Peking University People's Hospital:
|
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 |
Additional relevant MeSH terms:
|
Renal Insufficiency, Chronic Kidney Diseases Vitamin D Deficiency Calcinosis Renal Insufficiency Urologic Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Calcium Metabolism Disorders |
Metabolic Diseases Vitamins Vitamin D Ergocalciferols Hormones Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on September 27, 2016