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Phase IIB Clinical Trial Shows EVNol SupraBio™ Benefits Diabetic Nephropathy

Oral supplementation of EVNol SupraBio™ for 12 months significantly improves renal function

Oral supplementation of EVNol SupraBio™ for 12 months significantly improves renal function in diabetic nephropathy subjects as assessed by serum creatinine [1].

In 2014, the global prevalence of diabetes was reported by the World Health Organization (WHO) to be 8.5% (422 million adults), which is almost double the figure as compared to 4.7% (108 million adults) in 1980 [2]. Diabetic nephropathy (also known as diabetic kidney disease) is one of the microvascular complications of diabetes. This complication can lead to end-stage renal failure (ESRF), hence it is crucial to halt this complication from getting serious.

In a multicenter, double-blind, randomized placebo-controlled Phase IIB study, 59 diabetic nephropathy patients were randomized to receive either 200 mg EVNol SupraBio™ (encapsulated in softgel Tocovid Suprabio™) twice daily, or placebo. An increase in estimated glomerular filtration rate (eGFR) and a decrease in serum creatinine denote improvement in renal function. Patients with declined eGFR of ≥2 mL/min/1.73m2 per year will be identified as progressors and have higher chances to eventually progress to ESRF.

EVNol SupraBio™ supplementation significantly increased creatinine clearance and eGFR at twelve months of supplementation. These changes were sustained throughout the study period of a year. There was a reduction in serum creatinine levels of 7.85 umol/L in the EVNol SupraBio™ group with a corresponding 4.83 ml/min/1.73m2 increase of eGFR. On the other hand, subjects in the placebo group have a rate of eGFR declined in approximation to 2.26ml/min/1.73m2 over a year.

After 6 months of cessation of EVNol SupraBio™, a significant reduction in urine to albumin-creatinine ratio (UACR) by 19.3 mg/mmol was recorded. In contrast, placebo group showed an increase in UACR by 4.6 mg/mmol. The urine albumin-to-creatinine ratio (UACR) shows whether there is albumin in your urine. People with a high amount of albumin in their urine are at an increased risk of having chronic kidney disease progress to kidney failure.

As per the researcher’s knowledge, this is the first clinical trial that demonstrated tocotrienol-rich vitamin E supplementation for a short period of 12 months was able to ameliorate the progression of diabetic nephropathy especially in patients with stage 3 chronic kidney disease.

References

1.       Koay, Y. Y., Tan, G. C. J., Phang, S. C. W., Ho, J. I., Chuar, P. F., Ho, L. S., ... & Abdul Kadir, K. (2021). A Phase IIb Randomized Controlled Trial Investigating the Effects of Tocotrienol-Rich Vitamin E on Diabetic Kidney Disease. Nutrients, 13(1), 258.

2.       Global report on diabetes: World Health Organization; 2016.