Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients (EVIDENCE)

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease; Vitamin D Deficiency	Drug: Vitamin D2	Not Applicable

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

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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

Arms and Interventions

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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
No Intervention: Control; Not take Vitamin D2

Outcome Measures

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Primary Outcome Measures :

1. 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。

Secondary Outcome Measures :

1. 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。

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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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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

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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
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