Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Contrast-induced Nephropathy Clinical Trial

Official title:

Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02489240
• Other study ID #: PLAGH301
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2015
• Last updated: October 24, 2016
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: Chinese PLA General Hospital
• Contact: Yang Shi, M.D.
• Phone: +8610-66876231
• Email: ggyyong[@]sina.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• vitamin D3 tablets
2000 IU vitamin D3 tablets were taken daily for 6 days
• placebo
2000 IU placebo tablets were taken daily for 6 days

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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 — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	differences in the incidences of treatment-emergent adverse events	Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation	6 days after treatment	Yes
Primary	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	No
Secondary	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	No