Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Not Applicable

• Conditions: Contrast-induced Nephropathy
• Interventions: Drug: vitamin D3 tablets; Drug: placebo

• Registration Number: NCT02489240
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 306

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplementation group	vitamin D3 tablets	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.
Control group	placebo	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.

Primary Outcome Measures

Name	Time	Method
the prevalence of contrast-induced nephropathy	48-72h after treatment	The primary efficacy variable was the prevalence of CIN between the vitamin D group and the control group.

Secondary Outcome Measures

Name	Time	Method
a change in serum creatinine level	at 1, 2, 3 days after percutaneous coronary intervention	The change in serum creatinine level was measured at 1, 2, 3 days after the procedure.

Trial Locations

Locations (1)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China