Clinical trial NCT02489240: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Contrast-induced Nephropathy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the prevalence of contrast-induced nephropathy
timeFrame: 48-72h after treatment
Secondary outcomes:
measure: a change in serum creatinine level
timeFrame: at 1, 2, 3 days after percutaneous coronary intervention
Other outcomes:
measure: differences in the incidences of treatment-emergent adverse events
timeFrame: 6 days after treatment
Locations:
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
Study officials:
affiliation: PLA General Hospital
name: Yu Tang Wang, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.