Folic Acid for Prevention of Contrast Induced Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty.

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Detailed Description

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Hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (CIN) in previous studies. However, the relationship between homocysteine-lowering therapy and CIN remains uncertain. Folic acid is considered to be the most common agent for homocysteine-lowering therapy. Therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of CIN. 400 patients undergoing coronary CTA/angiography/angioplasty are going to be initially enrolled. Of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. Blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. CIN is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. The occurrence of CIN and the major in-hospital clinical events were recorded and compared between the intervention and control groups.

Conditions

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Kidney Diseases Urologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Folic acid

Oral folic acid (5 mg, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.

Group Type ACTIVE_COMPARATOR

Folic acid

Intervention Type DRUG

Placebo

Oral placebo (1 tablet, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Folic acid

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Folic uric acid

Eligibility Criteria

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Inclusion Criteria

* Inpatients undergoing coronary CTA/angiography/angioplasty

Exclusion Criteria

* exposure to nephrotoxic drugs prior to or during the study period
* end-stage renal failure requiring dialysis
* allergy to iodine-containing contrast medium
* pregnancy
* refusal to give informed consent

Eligible Sex

ALL

Accepts Healthy Volunteers

No