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Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Primary Purpose

Contrast-induced Nephropathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vitamin D3 tablets
placebo
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contrast-induced Nephropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The main inclusion criteria were patients who underwent coronary angiography.

Exclusion Criteria:

  • The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.
  • Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D supplementation group

Control group

Arm Description

drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: study treatment was commenced 3 days before intervention and maintained for 3 days after the procedure.

drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: study treatment was commenced 3 days before intervention and maintained for 3 days after the procedure.

Outcomes

Primary Outcome Measures

the prevalence of contrast-induced nephropathy
The primary efficacy variable was the prevalence of CIN between the vitamin D group and the control group.

Secondary Outcome Measures

a change in serum creatinine level
The change in serum creatinine level was measured at 1, 2, 3 days after the procedure.

Full Information

First Posted
July 1, 2015
Last Updated
October 24, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02489240
Brief Title
Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy
Official Title
Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators planned to research the effect of vitamin D supplementation on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography.
Detailed Description
Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Contrast-induced nephropathy (CIN) is a generally reversible form of acute kidney injury that occurs mostly within 2-3 days of exposure to contrast medium (CM). The estimated incidence of CIN ranges from 2%-50%, and coronary angiography (CAG) or percutaneous coronary intervention (PCI), or both, are associated with CIN in about half of cases. Recently low vitamin D status has been shown to be associated with increased risk of CIN. However, its effects on CIN patients remain unclear. The investigators planned to determine the efficacy of vitamin D on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in CIN patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D supplementation group
Arm Type
Experimental
Arm Description
drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: study treatment was commenced 3 days before intervention and maintained for 3 days after the procedure.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: study treatment was commenced 3 days before intervention and maintained for 3 days after the procedure.
Intervention Type
Drug
Intervention Name(s)
vitamin D3 tablets
Other Intervention Name(s)
Vigantoletten
Intervention Description
2000 IU vitamin D3 tablets were taken daily for 6 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2000 IU placebo tablets were taken daily for 6 days
Primary Outcome Measure Information:
Title
the prevalence of contrast-induced nephropathy
Description
The primary efficacy variable was the prevalence of CIN between the vitamin D group and the control group.
Time Frame
48-72h after treatment
Secondary Outcome Measure Information:
Title
a change in serum creatinine level
Description
The change in serum creatinine level was measured at 1, 2, 3 days after the procedure.
Time Frame
at 1, 2, 3 days after percutaneous coronary intervention
Other Pre-specified Outcome Measures:
Title
differences in the incidences of treatment-emergent adverse events
Description
Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation
Time Frame
6 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria were patients who underwent coronary angiography. Exclusion Criteria: The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders. Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Shi, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
hao wang, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Tang Wang, M.D.
Organizational Affiliation
PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Shi, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
First Name & Middle Initial & Last Name & Degree
Yu Tang Wang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
24680172
Citation
Sahin I, Gungor B, Can MM, Avci II, Guler GB, Okuyan E, Biter H, Yildiz SS, Ayca B, Satilmis S, Dinckal MH. Lower blood vitamin D levels are associated with an increased incidence of contrast-induced nephropathy in patients undergoing coronary angiography. Can J Cardiol. 2014 Apr;30(4):428-33. doi: 10.1016/j.cjca.2013.12.029. Epub 2014 Jan 4.
Results Reference
result
PubMed Identifier
22815410
Citation
Ari E, Kedrah AE, Alahdab Y, Bulut G, Eren Z, Baytekin O, Odabasi D. Antioxidant and renoprotective effects of paricalcitol on experimental contrast-induced nephropathy model. Br J Radiol. 2012 Aug;85(1016):1038-43. doi: 10.1259/bjr/16327485.
Results Reference
result
PubMed Identifier
23184900
Citation
Sokol SI, Srinivas V, Crandall JP, Kim M, Tellides G, Lebastchi AH, Yu Y, Gupta AK, Alderman MH. The effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease. Vasc Med. 2012 Dec;17(6):394-404. doi: 10.1177/1358863X12466709. Erratum In: Vasc Med. 2013 Feb;18(1):51. Lebastchi, Amir [corrected to Lebastchi, Amir H].
Results Reference
result

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Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

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