Contrast-induced NephropathyNCT02489240
Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy
A study testing vitamin D3 tablets in people with Contrast-induced Nephropathy, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Contrast-induced Nephropathy
- What is being tested?
- vitamin D3 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The main inclusion criteria were patients who underwent coronary angiography.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA General Hospital
Beijing, Beijing Municipality, 100853
Yang Shi, M.D., +8610-66876231, ggyyong@sina.com
Yu Tang Wang, M.D.
About this study
The investigators planned to research the effect of vitamin D supplementation on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography.
Read the 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.
- Conditions
- Contrast-induced Nephropathy
- Being tested
- vitamin D3 tablets, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3 tabletsDrug
Also called Vigantoletten
2000 IU vitamin D3 tablets were taken daily for 6 days
placeboDrug
2000 IU placebo tablets were taken daily for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation group | Experimental | 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. Receives: Drug: vitamin D3 tablets |
| Control group | Placebo comparator | 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of contrast-induced nephropathy
The primary efficacy variable was the prevalence of CIN between the vitamin D group and the control group.
Measured: 48-72h after treatment
Secondary outcomes (1)
a change in serum creatinine level
The change in serum creatinine level was measured at 1, 2, 3 days after the procedure.
Measured: at 1, 2, 3 days after percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yang, Chinese PLA General Hospital
- Investigators
- Yu Tang Wang, M.D., Study chair, PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489240
- Sponsor's protocol ID
- PLAGH301
- Status last verified
- Oct 2016
- First submitted
- 1 Jul 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. Can J Cardiol. 2014 Apr;30(4):428-33. doi: 10.1016/j.cjca.2013.12.029. Epub 2014 Jan 4.
PubMed 24680172Ari 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.
PubMed 22815410Sokol 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: 10.1177/1358863X12466709.
PubMed 23184900
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy
- ClinicalTrials.gov ID
- NCT02489240
- Acronym / sponsor ID
- PLAGH301
- Conditions
- Contrast-induced Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation group | Experimental | Drug: vitamin D3 tabletsdrug: 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 comparator | Drug: placebodrug: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The main inclusion criteria were patients who underwent coronary angiography.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3 tabletsAlso: Vigantoletten2000 IU vitamin D3 tablets were taken daily for 6 days | Drug | Vitamin D supplementation group |
| placebo2000 IU placebo tablets were taken daily for 6 days | Drug | Control group |
Primary outcome
the prevalence of contrast-induced nephropathy
Time frame: 48-72h after treatment
The primary efficacy variable was the prevalence of CIN between the vitamin D group and the control group.
1 secondary outcome
a change in serum creatinine level
Time frame: at 1, 2, 3 days after percutaneous coronary intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Results publication: PubMed 24680172Sahin 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. Can J Cardiol. 2014 Apr;30(4):428-33. doi: 10.1016/j.cjca.2013.12.029. Epub 2014 Jan 4.
- Results publication: PubMed 22815410Ari 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.
- Results publication: PubMed 23184900Sokol 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: 10.1177/1358863X12466709.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Tang Wang, M.D. study chair
PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 tablets in people with Contrast-induced Nephropathy, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Shi, M.D. (+8610-66876231, ggyyong@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of contrast-induced nephropathy (time frame: 48-72h after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489240, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.