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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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