Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy
The investigators planned to research the effect of vitamin D supplementation on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy|
- a change in the incidence of contrast-induced nephropathy [ Time Frame: 3 days after treatment ] [ Designated as safety issue: No ]The primary end point was a change in the incidence of contrast-induced nephropathy.
- a change in serum creatinine level [ Time Frame: at 1, 2, 3 days after percutaneous coronary intervention ] [ Designated as safety issue: No ]The change in serum creatinine level was measured at 1, 2, 3 days after the procedure.
- differences in the incidences of treatment-emergent adverse events [ Time Frame: 6 days after treatment ] [ Designated as safety issue: Yes ]Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D supplementation group
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
2000 IU vitamin D3 tablets were taken daily for 6 days
Other Name: Vigantoletten
Placebo Comparator: Control group
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.
2000 IU placebo tablets were taken daily for 6 days
Other Name: placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02489240
|Contact: Yang Shi, M.D.||+email@example.com|
|Contact: hao wang, M.D.||+firstname.lastname@example.org|
|PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Yang Shi, M.D. +8610-66876231 email@example.com|
|Principal Investigator: Yu Tang Wang, M.D.|
|Study Chair:||Yu Tang Wang, M.D.||PLA General Hospital|