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

This study is currently recruiting participants.
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
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:
Calcinosis
Kidney Diseases
Vitamin D Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Calcium Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency
Vitamin D
Ergocalciferols
Vitamins
Hormones
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 17, 2014