Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2

NCT ID: NCT01561222

Last Updated: 2015-06-08

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

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.

Detailed Description

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Conditions

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Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one pill per day

Calcitriol

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

0.25 ug per day for one year

Interventions

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Calcitriol

0.25 ug per day for one year

Intervention Type DRUG

placebo

one pill per day

Intervention Type DRUG

Other Intervention Names

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Rocaltrol

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of CKD stage 1 and 2
* Age \>18 years
* Ability to provide informed consent

Exclusion Criteria

* On vitamin D in past 4 weeks
* Plans to relocate out of Taixing City in the next one year
* Serum phosphate \>5.5 mg/dl in past 3 months
* Serum calcium \>10.0 mg/dl in past 3 months
* Cancer
* Transplanted organ
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taixing People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Zhang

Zhang Xu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taixing People's Hospital

Taishing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Xu Zhang, Bachelor

Role: CONTACT

008-613-905-266-789

Cai-xia Zhao, Master

Role: CONTACT

008-615-896-079-628

Facility Contacts

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Xu Zhang, bachelor

Role: primary

008-613-905-266-789

Other Identifiers

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zhangxu2012

Identifier Type: -

Identifier Source: org_study_id

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