scholarly journals Tocotrienol-Rich Vitamin E from Palm Oil (Tocovid) and Its Effects in Diabetes and Diabetic Nephropathy: A Pilot Phase II Clinical Trial

Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1315 ◽  
Author(s):  
Suzanne Tan ◽  
Yilynn Chiew ◽  
Badariah Ahmad ◽  
Khalid Kadir
Keyword(s):  
Blood Pressure ◽  
Diabetic Nephropathy ◽  
Vitamin E ◽  
Serum Creatinine ◽  
Palm Oil ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serum Biomarkers ◽  
Control Group ◽  
Potential Biomarker

Tocotrienol-rich vitamin E from palm oil (Tocovid) has been shown to ameliorate diabetes through its superior antioxidant, antihyperglycemic, and anti-inflammatory properties in diabetic rats. This study aimed to investigate the effects of Tocovid on diabetic nephropathy in patients with type 2 diabetes. Baseline parameters of potential subjects such as HbA1c, blood pressure, Advanced Glycation Endproduct (AGE), soluble receptor for AGE (sRAGE), Nε-Carboxymethyllysine (Nε-CML), and Cystatin C were assessed for possible correlation with diabetic nephropathy. Only subjects with diabetic nephropathy or urine microalbuminuria-positive defined as Urine Albumin to Creatinine Ratio (UACR) >10 mg/mmol were recruited into a prospective, randomized, double-blinded, placebo-controlled trial. The intervention group (n = 22) received Tocovid 200 mg twice a day while the control group (n = 23) received placebo twice a day for 8 weeks. Changes in Hemoglobin A1c (HbA1c), blood pressure, serum biomarkers and renal parameters such as UACR, serum creatinine, and estimated Glomerular Filtration Rate (eGFR) were compared between the two groups. It was found that serum Nε-CML significantly correlated to the severity of microalbuminuria. For every 1 ng/mL increase in serum Nε-CML, the odds of diabetic nephropathy increased by 1.476 times. Tocovid, compared to placebo, significantly reduced serum creatinine but not eGFR, UACR, HbA1c, blood pressure, and serum biomarkers. In conclusion, serum Nε-CML is a potential biomarker for diabetic nephropathy. Treatment with Tocovid significantly reduced serum creatinine; therefore Tocovid may be a useful addition to the current treatment for diabetic nephropathy.

scholarly journals The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1522
Author(s):  
Yeek Tat Ng ◽  
Sonia Chew Wen Phang ◽  
Gerald Chen Jie Tan ◽  
En Yng Ng ◽  
Nevein Philip Botross Henien ◽  
...  
Keyword(s):  
Vitamin E ◽  
Nerve Conduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serum Biomarkers ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Patients ◽  
Chronic Hyperglycemia ◽  
Conduction Velocities

Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group (n = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group (n = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35, p < 0.001, median nerve; +1.60 m/s, IQR 1.80, p < 0.001, sural nerve; +0.75 m/s, IQR 2.25, p < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.

scholarly journals A Phase IIb Randomized Controlled Trial Investigating the Effects of Tocotrienol-Rich Vitamin E on Diabetic Kidney Disease

Nutrients ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 258
Author(s):  
Yan Yi Koay ◽  
Gerald Chen Jie Tan ◽  
Sonia Chew Wen Phang ◽  
J-Ian Ho ◽  
Pei Fen Chuar ◽  
...  
Keyword(s):  
Vitamin E ◽  
Kidney Disease ◽  
Serum Creatinine ◽  
Diabetic Kidney Disease ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serum Biomarkers ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Vitamin E Supplementation

Diabetic kidney disease (DKD) is a debilitating complication of diabetes, which develops in 40% of the diabetic population and is responsible for up to 50% of end-stage renal disease (ESRD). Tocotrienols have shown to be a potent antioxidant, anti-inflammatory, and antifibrotic agent in animal and clinical studies. This study evaluated the effects of 400 mg tocotrienol-rich vitamin E supplementation daily on 59 DKD patients over a 12-month period. Patients with stage 3 chronic kidney disease (CKD) or positive urine microalbuminuria (urine to albumin creatinine ratio; UACR > 20–200 mg/mmol) were recruited into a randomized, double-blind, placebo-controlled trial. Patients were randomized into either intervention group (n = 31) which received tocotrienol-rich vitamin E (Tocovid SupraBioTM; Hovid Berhad, Ipoh, Malaysia) 400 mg daily or a placebo group which received placebo capsules (n = 28) for 12 months. HbA1c, renal parameters (i.e., serum creatinine, eGFR, and UACR), and serum biomarkers were collected at intervals of two months. Tocovid supplementation significantly reduced serum creatinine levels (MD: −4.28 ± 14.92 vs. 9.18 ± 24.96), p = 0.029, and significantly improved eGFR (MD: 1.90 ± 5.76 vs. −3.29 ± 9.24), p = 0.011 after eight months. Subgroup analysis of 37 patients with stage 3 CKD demonstrated persistent renoprotective effects over 12 months; Tocovid improved eGFR (MD: 4.83 ± 6.78 vs. −1.45 ± 9.18), p = 0.022 and serum creatinine (MD: −7.85(20.75) vs. 0.84(26.03), p = 0.042) but not UACR. After six months post washout, there was no improvement in serum creatinine and eGFR. There were no significant changes in the serum biomarkers, TGF-β1 and VEGF-A. Our findings verified the results from the pilot phase study where tocotrienol-rich vitamin E supplementation at two and three months improved kidney function as assessed by serum creatinine and eGFR but not UACR.

scholarly journals Tocotrienol-rich vitamin E from palm oil (Tocovid) and its effects in diabetes and diabetic retinopathy: a pilot phase II clinical trial

2021 ◽  
Vol 17 (4) ◽  
pp. 375-399
Author(s):  
Yilynn Chiew ◽  
Suzanne May Quinn Tan ◽  
Badariah Ahmad ◽  
Sim Ee Khor ◽  
Khalid Abdul Kadir
Keyword(s):  
Diabetic Retinopathy ◽  
Vitamin E ◽  
Palm Oil ◽  
Intervention Group ◽  
Retinal Hemorrhage ◽  
Current Treatment ◽  
Serum Biomarkers ◽  
Control Group ◽  
Strong Positive Correlation ◽  
The Right

Aim: To identify the effects of tocotrienol-rich vitamin E from palm oil (Tocovid) on diabetic retinopathy (DR) in patients with type 2 diabetes. Materials and methods: The intervention group (n = 21) received 200 mg Tocovid twice daily while the control group (n = 22) received placebo twice daily for 8 weeks. Changes in retinal photography by conventional grading and novel quantification of retinal hemorrhage were assessed. Changes in serum biomarkers advanced glycation end products (AGE) general, sRAGE (soluble receptor of AGE), Nε-CML (specific type of AGE), and cystatin C were evaluated. Results: A novel technique to quantify retinal hemorrhage had a strong positive correlation with conventional grading of DR in both eyes at baseline and at the end of the study. Eight-week supplementation of Tocovid resulted in significant reduction in retinal hemorrhage in the right eye. Liver enzymes and ALT significantly reduced. No significant changes in grade of DR, serum biomarkers, HbA1c, blood pressure, renal profile, and lipid profile were observed. Conclusions: Tocovid is a potential adjunct to current treatment of DR and fatty liver disease. A novel method of quantifying retinal hemorrhage is a potential technique for assessing disease severity of DR, particularly the early changes.

scholarly journals Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

2020 ◽  
Vol 17 (6) ◽  
pp. 2096
Author(s):  
Haiquan Xu ◽  
Yanzhi Guo ◽  
Shijun Lu ◽  
Yunqian Ma ◽  
Xiuli Wang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Systolic Blood Pressure ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Intervention Group ◽  
High Density Lipoproteins ◽  
Control Group ◽  
Randomized Controlled ◽  
Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

scholarly journals α-Tocopherol in breast milk of women with preterm delivery after a single postpartum oral dose of vitamin E

2016 ◽  
Vol 115 (8) ◽  
pp. 1424-1430 ◽  
Author(s):  
Jeane Franco Pires Medeiros ◽  
Karla Danielly da Silva Ribeiro ◽  
Mayara Santa Rosa Lima ◽  
Renata Alexandra Moreira das Neves ◽  
Amanda Cibely Pinheiro Lima ◽  
...  
Keyword(s):  
Vitamin E ◽  
Breast Milk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relevant Information ◽  
Maternal Serum ◽  
Tocopheryl Acetate ◽  
Control Group ◽  
Mature Milk ◽  
Tocopherol Concentration

AbstractWe evaluated the effect of maternal vitamin E supplementation on the α-tocopherol concentrations of colostrum, transitional milk and mature milk of women who had given birth prematurely. This longitudinal randomised-controlled trial divided eighty-nine women into two groups: a control group and a supplemented group. Blood and breast milk were collected from all the participants after delivery. Next, each woman in the supplemented group received 400 IU of RRR-α-tocopheryl acetate. Further breast milk samples were collected 24 h after the first collection, as well as 7 and 30 d after delivery. α-Tocopherol concentrations were determined by HPLC. The baseline α-tocopherol concentrations in the maternal serum of the two groups were similar: 1159·8 (sd 292·4) μg/dl (27·0 (SD 6·8) μmol/l) for the control group and 1128·3 (sd 407·2) μg/dl (26·2 (SD 9·5) μmol/l) for the supplemented group. None of the women was vitamin E deficient. Breast milk α-tocopherol concentrations increased by 60 % 24 h after supplementation in the intervention group and did not increase at all in the control group. α-Tocopherol concentration of the transitional milk in the supplemented group was 35 % higher compared with the control group. α-Tocopherol concentrations of the mature milk in both groups were similar. Maternal supplementation with 400 IU of RRR-α-tocopherol increased the vitamin E concentrations of the colostrum and transitional milk, but not of the mature milk. This study presents relevant information for the design of strategies to prevent and combat vitamin E deficiency in the risk group of preterm infants.

Abstract 6265: A Cluster Randomised Controlled Trial of Oscillometric Versus Manual Sphygmomanometers for Blood Pressure Management in Primary Care (CRAB)

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Mark R Nelson ◽  
Stephen Quinn ◽  
Linda Bowers-Ingram ◽  
Jan M Nelson ◽  
Tania M Winzenberg
Keyword(s):  
Blood Pressure ◽  
Antihypertensive Drugs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Digit Preference ◽  
Oscillometric Device ◽  
Prescribing Behaviour ◽  
Post Hoc

Although mercury sphygmomanometers are seen as the gold standard instrument for blood pressure (BP) measurement they are being withdrawn due to health and safety concerns. This has potential for changes in BP recording and management. CRAB aimed to determine the effect of an oscillometric device on digit preference, BP measurement and antihypertensive drug prescribing. Cluster randomized controlled trial in 24 family practices in Tasmania, Australia. Practices were excluded if they had oscillometric devices. Intervention practices were supplied with OMRON HEM-907 monitors for all clinical rooms and other BP measuring devices were removed. Three practices (2 control & 1 intervention) withdrew. Intervention practices had a 1 week run-in phase for familiarization and novelty reduction. Intervention practices were subsequently audited by a research nurse as prospective collection of data by a family physician may have influenced the outcome measures of interest. Control practice audit periods were matched to intervention practices. All analyses were ITT and adjusted for potential clustering. Differences in BP were analysed using generalised estimating equations. All other outcomes were analysed using multilevel mixed-effects poisson regression. Post hoc analyses were performed to determine the mediators of changes in prescribing behaviour. 3355 records were reviewed with 828 visits having BP recordings. The percentage of BP recordings ending in “0” was significantly lower in intervention vs. control practices [SBP 18% (233/329) vs. 71% (107/587), DBP 20% (229/328) vs. 70% (119/584) p<0.001]. The mean of systolic BP recordings in the intervention group was 7.5 mmHg (95% CI 5.2, 9.9 mmHg) higher than in the control group. Patients taking BP lowering drugs were more likely (IRR 1.3 95% CI 1.1, 1.7) to have a BP lowering drug prescribed if they were in the intervention compared to the control. Post hoc analyses identified systolic BP and not terminal digit preference as mediators of changes in prescribing behaviour. Oscillometric BP devices led to increases in overall prescribing of antihypertensive drugs. This was most likely mediated by reductions in measurement error leading to higher BP recordings.

scholarly journals Efficacy of Intralipid Infusion in Reducing Amphotericin-B–associated Nephrotoxicity in Head and Neck Invasive Fungal Infection: A Randomized, Controlled Trial

2017 ◽  
Vol 96 (2) ◽  
pp. E18-E22 ◽  
Author(s):  
Mehrdad Hasibi ◽  
Sirous Jafari ◽  
Seyyed Ali Dehghan Manshadi ◽  
Marjan Asadollahi ◽  
Mohammadreza Salehi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Serum Creatinine ◽  
Amphotericin B ◽  
Fungal Infections ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Baseline Serum ◽  
Randomized Controlled ◽  
Amphotericin B Deoxycholate

Amphotericin B deoxycholate (ABD) is the best therapeutic agent available for the treatment of most systemic fungal infections. However, some untoward adverse effects such as nephrotoxicity may limit its appropriate therapeutic use. We conducted a randomized, controlled trial ofthe infusion of fat emulsion (Intralipid) shortly after the infusion of ABD to evaluate its effects on reducing ABD-associated nephrotoxicity. Our patient population was made up of 31 patients who were randomized into two groups: an intervention group (n = 16) and a control group (15 patients). There were no statistically significant differences between the two groups in demographic or clinical variables. All patients received 1mg/kg/day of ABD in dextrose 5%. In addition, the patients in the intervention arm received Intralipid 10%, which was started as soon as possible within 1 hour after the infusion of ABD. ABD-associated nephrotoxicity was defined as a minimum 50% increase in baseline serum creatinine to a minimum of 2mg/dl. We also measured daily serum creatinine changes during the first 2 weeks of treatment, and we compared some other relevant indices of renal function, as well as ABD-related hypokalemia. We found no statistically significant differences between the two treatments in terms of ABD-associated nephrotoxicity or any of the other indices. We conclude that the administration of Intralipid 10% early after infusion of ABD in dextrose 5% does not have any effect in decreasing ABD-associated nephrotoxicity or hypokalemia.

The Effects of Home-Based Self-Care Education on Blood Pressure and Self-Care Behaviors among Middle-Aged Patients with Primary Hypertension in Iran: A Randomized Clinical Controlled Trial

2021 ◽  
pp. 108482232110127
Author(s):  
Sara Hazrati Gonbad ◽  
Masoumeh Zakerimoghadam ◽  
Shahzad Pashaeypoor ◽  
Shima Haghani
Keyword(s):  
Blood Pressure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Primary Hypertension ◽  
Control Group ◽  
Middle Aged ◽  
Aged Patients ◽  
Care Education ◽  
Home Based

Self-care education (SCE) through home visit is one of the methods with potential effects on self-care. This study aimed to evaluate the effects of home-based SCE on blood pressure and self-care behaviors among middle-aged patients with primary hypertension in Iran. This randomized controlled trial was conducted on 110 middle-aged patients with hypertension recruited from public healthcare centers in the south of Tehran, Iran in September 2019. After convenience sampling, Participants were simple randomly allocated to control and intervention groups. Intervention group received a 2-month home-based SCE while control group received routine care services. Before and 2 months after the intervention, self-care behaviors were assessed using the Hypertension Self-Care Activity Level Effects (H-SCALE). Data were analyzed using the SPSS software (v. 16.0) at a significance level of less than .05. After 2 months, the posttest mean scores of self-care behaviors in medication adherence (17.42 ± 1.03 vs 14.49 ± 1.01, p = .04), physical activity (8.16 ± 0.39 vs 6.47 ± 0.52, p = .01), low-salt diet (52.51 ± 3.8 vs 35.36 ± 3.47, p = .001), and blood pressure control (3.47 ± 0.22 vs 2.42 ± 1.89, p = .001), in the intervention group were significantly greater than the control group. However, there were no significant between-group differences respecting the posttest mean scores of the weight management ( p = .06) and smoking cessation ( p = .2). Also, the mean blood pressure between the 2 groups changed after the intervention, but this difference was not statistically significant. This study suggests the effectiveness of home-based SCE in significantly improving self-care behaviors among patients with hypertension. But more studies are needed to measure the effectiveness of intervention on blood pressure. IRCT code: IRCT20190623043985N1. Registered 06/30/2019, https://fa.irct.ir/trial/40351 .

scholarly journals Lifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Su Lin Lim ◽  
Jolyn Johal ◽  
Kai Wen Ong ◽  
Chad Yixian Han ◽  
Yiong Huak Chan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Weight Loss ◽  
Fatty Liver ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Control Group ◽  
Nonalcoholic Fatty Liver ◽  
Randomized Controlled

BACKGROUND The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. OBJECTIVE We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. METHODS This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m<sup>2</sup> who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. RESULTS The intervention group had a 5-fold higher likelihood (relative risk 5.2, <i>P</i>=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; <i>P</i>&lt;.001), waist circumference (mean 2.9, SD 5.0 cm vs mean –0.7, SD 4.4 cm; <i>P</i>&lt;.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; <i>P</i>=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean –0.9, SD 10.0 mmHg; <i>P</i>=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; <i>P</i>=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, <i>P</i>=.03) at 6 months. CONCLUSIONS Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp

scholarly journals Tocotrienol-rich vitamin E improves diabetic nephropathy and persists 6–9 months after washout: a phase IIa randomized controlled trial

2019 ◽  
Vol 10 ◽  
pp. 204201881989546
Author(s):  
Gerald Chen Jie Tan ◽  
Suzanne May Quinn Tan ◽  
Sonia Chew Wen Phang ◽  
Yeek Tat Ng ◽  
En Yng Ng ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Diabetic Nephropathy ◽  
Vitamin E ◽  
Serum Creatinine ◽  
Human Subjects ◽  
Controlled Trial ◽  
Serum Vitamin ◽  
Mean Difference ◽  
Controlled Clinical Trial ◽  
Chronic Hyperglycemia

Chronic hyperglycemia in type 2 diabetes mellitus increases oxidative stress and inflammation which contributes to long-term diabetic kidney disease. Tocotrienol-rich vitamin E, as Tocovid, has been shown to reduce oxidative stress and inflammation to ameliorate diabetes in rat models and human subjects. In this prospective, multicenter, double-blinded, placebo-controlled clinical trial, 54 patients (duration = 18.4 years, HbA1c = 8.8%) with diabetic nephropathy were randomized to receive Tocovid 200 mg or placebo for 12 weeks. Fasting blood samples were taken to measure HbA1c, serum creatinine, estimate glomerular filtration rate (eGFR), urine albumin:creatinine ratio, malondialdehyde, tumor necrosis factor receptor-1, vascular cell adhesion molecule-1 (VCAM-1), and thromboxane-B2. Patients were reassessed 6–9 months post-washout. After 12 weeks of supplementation, Tocovid significantly decreased serum creatinine levels (mean difference: –3.3 ± 12.6 versus 5.4 ± 14.2, p = 0.027) and significantly increase eGFR (mean difference: 1.5 ± 7.6 versus –2.9 ± 8.0, p = 0.045) compared with placebo. There were no significant changes in HbA1c, blood pressure, and other parameters. Subgroup analysis revealed that in patients with low serum vitamin E concentrations at baseline, Tocovid reduced serum creatinine, eGFR, and VCAM-1 significantly. After 6–9 months of washout, persistent difference in serum creatinine remained between groups (mean difference: 0.82 ± 8.33 versus 11.26 ± 15.47, p = 0.031), but not eGFR. Tocovid at 400 mg/day significantly improved renal function in 12 weeks of supplementation, as assessed by serum creatinine and eGFR, which remained significant 6–9 months post-washout.

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