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

NCT ID: NCT01672047

Last Updated: 2012-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Disease Vitamin D Deficiency

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treament

Intervention Vitamin D2

Group Type EXPERIMENTAL

Vitamin D2

Intervention Type DRUG

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.

Control

Not take Vitamin D2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Vitmain D2 capsule

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Mei

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mei Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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The People's Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Sui Zhun, MD

Role: primary

Wang Mei, MD

Role: backup

Other Identifiers

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PURCP201103

Identifier Type: -

Identifier Source: org_study_id