Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Contrast-induced Nephropathy

Treatments: Drug: placebo; Drug: vitamin D3 tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT02489240

PLAGH301

Details and patient eligibility

About

The investigators planned to research the effect of vitamin D supplementation on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography.

Full 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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 2 patient groups, including a placebo group

Vitamin D supplementation group

Experimental group

Description:

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.

Treatment:

Drug: vitamin D3 tablets

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo