Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Conditions
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Contrast-induced Nephropathy

Intervention / Treatment
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* Drug: vitamin D3 tablets
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D supplementation group<br>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<br>* 2000 IU vitamin D3 tablets were taken daily for 6 days<br>* Other names: Vigantoletten;|
| Placebo Comparator: Control group<br>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<br>* 2000 IU placebo tablets were taken daily for 6 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in serum creatinine level | The change in serum creatinine level was measured at 1, 2, 3 days after the procedure. | at 1, 2, 3 days after percutaneous coronary intervention |