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Folic acid and vitamin B12 supplementation in subjects with type 2 diabetes mellitus: A multi-arm randomized controlled clinical trial.
Satapathy, S, Bandyopadhyay, D, Patro, BK, Khan, S, Naik, S
Complementary therapies in medicine. 2020;:102526
Abstract
OBJECTIVE This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus. STUDY DESIGN & INTERVENTION This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups - Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks. RESULTS HbA1c improved significantly in Groups B and C [median changes from baseline - 1.2 % (- 13 mmol/mol) and - 1.5 % (- 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups. CONCLUSIONS Add-on supplementation with vitamin B12 improved glycaemic control and insulin resistance in patients with type 2 diabetes mellitus.
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Clinical Trial Assessing the Efficacy of Gabapentin Plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy.
Mimenza Alvarado, A, Aguilar Navarro, S
Journal of diabetes research. 2016;:4078695
Abstract
INTRODUCTION Painful diabetic neuropathy (PDN) is a prevalent and impairing disorder. The objective of this study was to show the efficacy and safety of gabapentin (GBP) plus complex B vitamins: thiamine (B1) and cyanocobalamine (B12) compared to pregabalin in patients with moderate to severe intensity PDN. METHOD Multicenter, randomized, blind study. Two hundred and seventy patients were evaluated, 147 with GBP/B1/B12 and 123 with PGB, with a 7/10 pain intensity on the Visual Analog Scale (VAS). Five visits (12 weeks) were scheduled. The GBP/B1 (100 mg)/B12 (20 mg) group started with 300 mg at visit 1 to 3600 mg at visit 5. The PGB group started with 75 mg/d at visit 1 to 600 mg/d at visit 5. Different safety and efficacy scales were applied, as well as adverse event assessment. RESULTS Both drugs showed reduction of pain intensity, without significant statistical difference (P = 0.900). In the GBP/B1/B12 group, an improvement of at least 30% on VAS correlated to a 900 mg/d dose, compared with PGB 300 mg/d. Likewise, occurrence of vertigo was lower in the GBP/B1-B12 group, with a significant statistical difference, P = 0.014. CONCLUSIONS Our study shows that GPB/B1-B12 combination is as effective as PGB. Nonetheless, pain intensity reduction is achieved with 50% of the minimum required gabapentin dose alone (800 to 1600 mg/d) in classic NDD trials. Less vertigo and dizziness occurrence was also observed in the GBP/B1/B12 group. This trial is registered with ClinicalTrials.gov NCT01364298.
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Anaerobic biosynthesis of the lower ligand of vitamin B12.
Hazra, AB, Han, AW, Mehta, AP, Mok, KC, Osadchiy, V, Begley, TP, Taga, ME
Proceedings of the National Academy of Sciences of the United States of America. 2015;(34):10792-7
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Abstract
Vitamin B12 (cobalamin) is required by humans and other organisms for diverse metabolic processes, although only a subset of prokaryotes is capable of synthesizing B12 and other cobamide cofactors. The complete aerobic and anaerobic pathways for the de novo biosynthesis of B12 are known, with the exception of the steps leading to the anaerobic biosynthesis of the lower ligand, 5,6-dimethylbenzimidazole (DMB). Here, we report the identification and characterization of the complete pathway for anaerobic DMB biosynthesis. This pathway, identified in the obligate anaerobic bacterium Eubacterium limosum, is composed of five previously uncharacterized genes, bzaABCDE, that together direct DMB production when expressed in anaerobically cultured Escherichia coli. Expression of different combinations of the bza genes revealed that 5-hydroxybenzimidazole, 5-methoxybenzimidazole, and 5-methoxy-6-methylbenzimidazole, all of which are lower ligands of cobamides produced by other organisms, are intermediates in the pathway. The bza gene content of several bacterial and archaeal genomes is consistent with experimentally determined structures of the benzimidazoles produced by these organisms, indicating that these genes can be used to predict cobamide structure. The identification of the bza genes thus represents the last remaining unknown component of the biosynthetic pathway for not only B12 itself, but also for three other cobamide lower ligands whose biosynthesis was previously unknown. Given the importance of cobamides in environmental, industrial, and human-associated microbial metabolism, the ability to predict cobamide structure may lead to an improved ability to understand and manipulate microbial metabolism.
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Vitamin B12 deficiency in patients undergoing bariatric surgery: preventive strategies and key recommendations.
Majumder, S, Soriano, J, Louie Cruz, A, Dasanu, CA
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2013;(6):1013-9
Abstract
BACKGROUND Advances in bariatric surgery have brought about a paradigm shift in the management of obesity, with benefits extending beyond weight loss. However, nutritional deficiencies are an inherent problem in the postoperative period and often require lifelong supplementation. Vitamin B12, also referred to as cobalamin, is one of the most common micronutrient deficiencies affecting this population. This review explores the pathophysiology of cobalamin deficiency in patients undergoing bariatric surgery and provides an overview of the effectiveness of various available vitamin B12 formulations. METHODS To identify the relevant literature, a systematic review of MEDLINE was conducted from the earliest dates through September 2012 for English-language articles describing the prevention and management of vitamin B12 deficiency in patients undergoing bariatric surgery. RESULTS Intramuscular vitamin B12 continues to be the gold standard of therapy for vitamin B12 deficiency, especially in symptomatic patients. In select patients with asymptomatic vitamin B12 deficiency after Roux-en-Y gastric bypass (RYGB), high-dose oral cyanocobalamin should be given a consideration, especially when there are concerns with the adherence to intramuscular therapy or if compliance comes into question. Unlike patients post-RYGB, those undergoing restrictive procedures such as gastric banding and sleeve gastrectomy may be maintained postoperatively on a lower-dose daily vitamin B12 supplementation. Efficacy data of nasal and sublingual routes for maintenance therapy is currently awaited. CONCLUSION Patients undergoing bariatric surgery must be continuously educated on proper nutrition, the risk of developing significant vitamin B12 deficiency, and the role of supplements in avoiding catastrophic consequences.
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Antenatal iron supplements consumed daily produce oxidative stress in contrast to weekly supplementation in Mexican non-anemic women.
Viteri, FE, Casanueva, E, Tolentino, MC, Díaz-Francés, J, Erazo, AB
Reproductive toxicology (Elmsford, N.Y.). 2012;(1):125-32
Abstract
UNLABELLED Universal prenatal daily supplementation with iron (60-120mg iron) plus folic acid (0.4mg), as recommended by INACG/WHO/UNICEF, prevents anemia where iron deficiency is prevalent but may be excessive for non-anemic women. Weekly supplementation with 120mg iron plus various amounts of folic acid similarly prevents significant anemia. OBJECTIVE Determine, in non-anemic pregnant women, if oxidative stress is produced by recommended daily or weekly supplementation schemes. PROCEDURE 100 non-anemic pregnant women, 30% iron-deficient at week 20, were randomly supplemented daily followed by weekly, each for 8 weeks, or in reversed order. RESULTS With daily supplementation thio-barbituric-acid-reacting-substances (TBARS) increased significantly and high serum ferritin, iron, and excessively elevated hemoglobin occurred near term. During weekly supplementation significant anemia and high iron parameters were prevented, and elevated TBARS declined. CONCLUSION In non-anemic pregnant women both schemes prevented significant anemia. Oxidative stress occurred only during daily supplementation periods. Weekly supplementation appears safer.
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Modulation of serum gastric parietal cell antibody level by levamisole and vitamin B12 in oral lichen planus.
Lin, HP, Wang, YP, Chia, JS, Chiang, CP, Sun, A
Oral diseases. 2011;(1):95-101
Abstract
OBJECTIVES The objective of this study was to test the efficacy of three different treatment modalities on the reduction of serum anti-gastric parietal cell autoantibody (GPCA) level in GPCA-positive oral lichen planus (OLP) patients. MATERIALS AND METHODS Of 147 GPCA-positive OLP patients, 100 were treated with levamisole plus vitamin B12, 10 with vitamin B12 only and 37 with levamisole only. The serum GPCA levels in 147 OLP patients were measured at baseline and after treatment. RESULTS Treatment with levamisole plus vitamin B12 for a period of 2-50 months and treatment with vitamin B12 only for a period of 4-44 months could effectively reduce the high serum GPCA level to undetectable level in 100 and 10 OLP patients, respectively. However, treatment with levamisole only for a period of 2-50 months could not modulate the high mean serum GPCA titer to a significantly lower level in 37 OLP patients. A 92% GPCA recurrence rate was found in 25 OLP patients receiving no further vitamin B12 treatment during the GPCA-negative remission period. CONCLUSION For GPCA-positive OLP patients, treatment modality containing vitamin B12 can effectively reduce the high serum GPCA level to undetectable level. OLP patients with underlying autoimmune atrophic gastritis trait should receive a maintenance vitamin B12 treatment for life.
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Alcohol increases homocysteine and reduces B vitamin concentration in healthy male volunteers--a randomized, crossover intervention study.
Gibson, A, Woodside, JV, Young, IS, Sharpe, PC, Mercer, C, Patterson, CC, McKinley, MC, Kluijtmans, LA, Whitehead, AS, Evans, A
QJM : monthly journal of the Association of Physicians. 2008;(11):881-7
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Abstract
BACKGROUND Few studies have examined the effect of alcohol consumption on total homocysteine (tHcy) concentrations. AIM: To assess the effect of an 8-week intervention with vodka or red wine on plasma tHcy and B vitamin concentrations in healthy male volunteers. To assess the effect on tHcy according to methylenetetrahydrofolate reductase (MTHFR) 677C>T genotype. DESIGN AND METHODS A randomized controlled crossover intervention study measuring tHcy and serum folate and vitamin B(12) concentrations was conducted in 78 male subjects (21-70 years). Following a 2-week washout period during which no alcohol was consumed, all subjects consumed 24 g alcohol (either 240 ml red wine or 80 ml vodka)/day for a 2-week period. Following a further 2-week washout, participants consumed the alternate intervention for 2 weeks. RESULTS A significant increase in plasma tHcy was observed after the 2-week red wine intervention (5%, P = 0.03), and a non-significant increase in tHcy with vodka intervention (3%, P = 0.09). When the two interventions were compared, the change in tHcy did not differ between the vodka and red wine interventions (P = 0.57). There were significant decreases in serum vitamin B(12) and folate concentrations, and this decrease did not differ between interventions. The increase in tHcy observed in both interventions did not vary by MTHFR 677C>T genotype. CONCLUSION A 2-week alcohol intervention resulted in a decrease in folate and vitamin B(12) status and an increase in plasma tHcy. The effect of alcohol intervention on tHcy, folate and vitamin B(12) concentrations did not differ between the red wine and vodka intervention groups.
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Plasma homocysteine, folate, and vitamin B 12 and the risk of hip fracture: the hordaland homocysteine study.
Gjesdal, CG, Vollset, SE, Ueland, PM, Refsum, H, Meyer, HE, Tell, GS
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2007;(5):747-56
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UNLABELLED Homocysteine and related factors were evaluated as risk factors for subsequent hip fractures among 4766 elderly men and women. High levels of homocysteine and low levels of folate predicted fracture, whereas vitamin B12 and genotypes were not related to fracture risk. High homocysteine may be a modifiable risk factor for hip fracture. INTRODUCTION Elevated plasma total homocysteine (tHcy) and deficiencies of folate and vitamin B12 are associated with risk of osteoporosis and fracture. We examined whether plasma levels of tHcy, folate, and vitamin B12 and the methylenetetrahydrofolate reductase (MTHFR) 677C-->T and 1298C-->T polymorphisms predicted hip fracture. MATERIALS AND METHODS This was a population-based prospective study of 2639 women and 2127 men who were 65-67 yr at enrollment in 1992-1993. Information on hip fracture was obtained from computerized records of discharge diagnoses from all hospitalizations in the region in the period between enrollment and November 30, 2005. Cox proportional hazard regression was used to estimate fracture risk according to levels of plasma tHcy, folate, and vitamin B12 and for different genotypes. RESULTS Over a median follow-up period of 12.6 yr, hip fracture was recorded in 184 (7.0%) women and 90 (4.2%) men. The adjusted hazard ratio (95% CI) for fracture in subjects with high (>or=15 microM) compared with low levels (<9.0 microM) of tHcy was 2.42 (1.43-4.09) among women and 1.37 (0.63-2.98) among men. Dose-response analyses indicated a positive association between plasma tHcy and risk of fracture in both sexes and a negative association between plasma folate and risk of fracture among women only. Plasma vitamin B12 level or MTHFR genotype was not significantly related to risk of fracture after adjustments for confounding factors. The association between tHcy and risk of hip fracture was only slightly weakened by adjustments for plasma levels of vitamin B12 and folate. CONCLUSIONS tHcy seems to be a predictor for hip fracture among elderly men and women. Folate was a predictor among women only, whereas vitamin B12 and MTHFR genotype did not predict hip fracture. Our data corroborate the hypothesis that homocysteine may play a role in the pathogenesis of osteoporotic fractures.
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Homocysteine, folate and cobalamin levels in hypothyroid women before and after treatment.
Orzechowska-Pawilojc, A, Sworczak, K, Lewczuk, A, Babinska, A
Endocrine journal. 2007;(3):471-6
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Hypothyroidism may result in accelerated atherosclerosis. Hyperhomocysteinaemia is an independent risk factor for premature atherosclerotic vascular disease. The aim of the present study was to assess plasma total homocysteine (tHcy), folate and cobalamin concentrations in hypothyroid patients before and after treatment. Thirty-one hypothyroid and thirty health young women were studied. The hypothyroid patients were investigated in the untreated state and again after restoration of euthyroidism. The levels of homocysteine, folate, cobalamin and thyroid stimulating hormone (TSH), free thyroxine (fT(4)), free triiodothyronine (fT(3)) and renal function were measured before and after treatment. In hypothyroidism tHcy was higher but not statistically significant than in control group. Serum level of folate was higher and serum cobalamin was lower in the hypothyroid state. Following L-thyroxine therapy tHcy significantly decreased as well as the concentration of cobalamin. Level of folate remained unchanged. Univariate analysis in hypothyroid group indicated that tHcy negative correlated with creatinine clearance, fT(3), fT(4), cobalamin and positive with TSH. In multivariate analysis tHcy correlated with creatinine clearance, cobalamin and fT(4). Thyroid status influences the plasma tHcy. Free triiodothyronine and next free thyroxine have the greatest negative influence. This would account for hyperhomocysteinemia in the hypothyroid state and premature atherogenesis.
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[Better prognosis for stroke patients].
Spence, JD
MMW Fortschritte der Medizin. 2006;(20):64