Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients (EVIDENCE)
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ClinicalTrials.gov Identifier: NCT01672047 |
Recruitment Status
: Unknown
Verified August 2012 by Wang Mei, Peking University People's Hospital.
Recruitment status was: Recruiting
First Posted
: August 24, 2012
Last Update Posted
: August 30, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease Vitamin D Deficiency | Drug: Vitamin D2 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | April 2014 |
Estimated Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
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
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No Intervention: Control
Not take Vitamin D2
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- 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。
- the improvement of proteinuria [ Time Frame: 2 years ]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。

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672047
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 |
Principal Investigator: | Mei Wang, MD, PhD | Peking University People's Hospital |
Responsible Party: | Wang Mei, Professor, Peking University People's Hospital |
ClinicalTrials.gov Identifier: | NCT01672047 History of Changes |
Other Study ID Numbers: |
PURCP201103 |
First Posted: | August 24, 2012 Key Record Dates |
Last Update Posted: | August 30, 2012 |
Last Verified: | August 2012 |
Keywords provided by Wang Mei, 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:
Kidney Diseases Renal Insufficiency, Chronic Vitamin D Deficiency Calcinosis Urologic Diseases Renal Insufficiency 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 |