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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Peking University People's Hospital
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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:
Kidney Diseases
Vitamin D Deficiency
Renal Insufficiency, Chronic
Calcinosis
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014