Trial record 2 of 193756 for:    ALL

Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Shi Yang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT02489240
First received: July 1, 2015
Last updated: NA
Last verified: July 2015
History: No changes posted
  Purpose

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


Condition Intervention
Contrast-induced Nephropathy
Drug: vitamin D3 tablets
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 72
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)
Arms Assigned Interventions
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.
Drug: placebo
2000 IU placebo tablets were taken daily for 6 days
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02489240

Contacts
Contact: Yang Shi, M.D. +8610-66876231 ggyyong@sina.com
Contact: hao wang, M.D. +8610-66876231 ggyyong@sina.com

Locations
China, Beijing
PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yang Shi, M.D.    +8610-66876231    ggyyong@sina.com   
Principal Investigator: Yu Tang Wang, M.D.         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: Yu Tang Wang, M.D. PLA General Hospital
  More Information

Publications:
Responsible Party: Shi Yang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02489240     History of Changes
Other Study ID Numbers: PLAGH301
Study First Received: July 1, 2015
Last Updated: July 1, 2015
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 01, 2015