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 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 effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mostafa Hemamy ◽  
Naseh Pahlavani ◽  
Alireza Amanollahi ◽  
Sheikh Mohammed Shriful Islam ◽  
Jenna McVicar ◽  
...  
Keyword(s):  
Mental Health ◽  
Vitamin D ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Magnesium Supplementation ◽  
Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

Efficacy of Integrative Body-Mind-Spirit Group Intervention for Parents of Children With Eczema: A Randomized, Wait-List Controlled Clinical Trial

2020 ◽  
Vol 30 (6) ◽  
pp. 623-632
Author(s):  
Yat-Lui Fung ◽  
Hiu-Tin Leung ◽  
Celia H. Y. Chan ◽  
Bobo H. P. Lau ◽  
Cecilia L. W. Chan
Keyword(s):  
Psychosocial Intervention ◽  
Group Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Empirical Support ◽  
Well Being ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Wait List ◽  
Reducing Stress

Objectives: This randomized controlled trial evaluated the effects of a psychosocial intervention developed based on the Integrative Body-Mind-Spirit (IBMS) model that aimed to enhance the well-being of parents of children with eczema. Methods: Ninety-one families were randomly allocated to either the six-session intervention group ( n = 48) or the wait-list control group ( n = 43) and completed the randomized trial. For both groups, a range of psychosocial outcome measures were taken before the intervention (T0), postintervention (T1), and 6 weeks after the intervention (T2). Results: Relative to the control group, the intervention group was significantly improved over time in their levels of perceived stress, depression, and a number of holistic well-being measures, including nonattachment, afflictive ideation, and general vitality. Discussion: The results provided empirical support for an IBMS-informed psychosocial intervention in reducing stress and depression and enhancing well-being among parents of children with eczema.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals Positive Effect of Vitamin D and Magnesium Supplementation on Mental health Status of Attention-Deficit Hyperactive Children; A Randomized Double blind Controlled Clinical Trial

2020 ◽  
Author(s):  
Mostafa Hemamy ◽  
Naseh Pahlavani ◽  
Gholamreza Askari ◽  
Mahsa Malekahmadi
Keyword(s):  
Mental Health ◽  
Vitamin D ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Magnesium Supplementation ◽  
Double Blind

Abstract Background: Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in ADHD. The aim of this study is to determine the effect of Vitamin D and magnesium supplementation on mental health in children with ADHD.Method: This double‑blind, randomized controlled trial was performed on 66 ADHD children. participants were randomly allocated to receive both Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8 weeks. Strengths and difficulties questionnaire were used to evaluate children’s mental health at baseline and at the end of the study.Results: After 8 weeks of intervention, the serum levels of 25‑hydroxy‑Vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also a significant decrease in changes of emotional problems (p=0.001), conduct problems (p=0.002), peer problems (p=0.001), prosocial score (p=0.007), total difficulties (p=0.001), externalizing score (p=0.001), and internalizing score (p=0.001) was seen in intervention group at the end of study.Conclusion: Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation during 8-week could improve the behavioral function and mental health in ADHD. Although further well-designed studies with a larger sample size are needed.the IRCT registration: IRCT2016030326886N1.

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.

scholarly journals Diets enriched with whole grains reduce premenstrual syndrome scores in nurses: an open-label parallel randomised controlled trial

2019 ◽  
Vol 121 (09) ◽  
pp. 992-1001 ◽  
Author(s):  
Mozhgan Esmaeilpour ◽  
Sedigheh Ghasemian ◽  
Mohammad Alizadeh
Keyword(s):  
Clinical Trial ◽  
Premenstrual Syndrome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Whole Grains ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Daily Consumption ◽  
Open Label ◽  
Refined Grains

AbstractAlthough previous studies have demonstrated the beneficial effects of some components of whole grains on premenstrual syndrome (PMS), our literature review shows that no clinical trial has studied the effect of whole grain consumption on PMS so far. Therefore, the present study was designed to study the effect of diets rich in whole grains on PMS among nurses. This study is a parallel controlled clinical trial with a 3-month intervention period in which, after following two menstrual cycles among nurses, 100 nurses diagnosed with PMS were randomly divided into two groups of intervention and control, with fifty individuals in each. Those in the intervention group replaced at least four servings of refined grains in their daily diets with whole grains. To supply four servings, 120 g of bread made with whole flour was given to the intervention group on a daily basis. Those in the control group, however, continued their regular daily consumption of grains. The two groups were compared regarding PMS symptoms after adjusting the confounding variables. The repeated measurement test showed that the interaction between the time factor and the experimental group on the mean score of PMS symptoms was significant. That is, the intervention group showed a significant decrease in the general, mood, physical and behavioural symptoms of PMS compared with the controls (P&lt;0·001, P=0·01, P&lt;0·001 and P=0·003, respectively). Therefore, daily consumption of whole grains in place of refined grains can contribute to improvement in PMS symptoms. Further studies are needed to confirm our findings.

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