NCT01561222

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
3.3 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

March 19, 2012

Last Update Submit

June 5, 2015

Conditions

Chronic Kidney Disease Stage 1Chronic Kidney Disease Stage 2

Keywords

calcitrolBone mineral densityOsteoproteginVascular calcification

Outcome Measures

Primary Outcomes (1)

  • Osteoprotegin level

    To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients

    one year

Secondary Outcomes (2)

  • Bone mineral density

    one year

  • vascular calcification score

    one year

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: placebo

Calcitriol

EXPERIMENTAL
Drug: Calcitriol

Interventions

CalcitriolDRUG

0.25 ug per day for one year

Also known as: Rocaltrol
Calcitriol
placeboDRUG

one pill per day

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taixing People's Hospital

Taishing, Jiangsu, 225400, China

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicVascular Calcification

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

Xu Zhang, Bachelor

CONTACT

008-613-905-266-789dr.zhangxu@tom.com

Cai-xia Zhao, Master

CONTACT

008-615-896-079-628zhaocaixia2010@yahoo.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhang Xu

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 22, 2012

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CN(1)