NCT02489240

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

July 1, 2015

Last Update Submit

October 24, 2016

Conditions

Contrast-induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • the prevalence of contrast-induced nephropathy

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

    48-72h after treatment

Secondary Outcomes (1)

  • a change in serum creatinine level

    at 1, 2, 3 days after percutaneous coronary intervention

Other Outcomes (1)

  • differences in the incidences of treatment-emergent adverse events

    6 days after treatment

Study Arms (2)

Vitamin D supplementation group

EXPERIMENTAL

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: vitamin D3 tablets

Control group

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

vitamin D3 tabletsDRUG

2000 IU vitamin D3 tablets were taken daily for 6 days

Also known as: Vigantoletten
Vitamin D supplementation group
placeboDRUG

2000 IU placebo tablets were taken daily for 6 days

Control group

Eligibility Criteria

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

You may not qualify if:

  • Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24680172RESULT

  • 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.

    PMID: 22815410RESULT

  • 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.

    PMID: 23184900RESULT

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Yu Tang Wang, M.D.

    PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Yang Shi, M.D.

CONTACT

+8610-66876231ggyyong@sina.com

hao wang, M.D.

CONTACT

+8610-66876231ggyyong@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shi Yang

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 2, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

CN(1)