-
1.
Efficacy of a topical herbal and mineral formulation (Dynamiclear) for the treatment of herpes simplex labialis in the community setting: study protocol for a randomised, double-blind placebo-controlled trial.
Armour, M, Semprini, A, Ee, C, MacCullagh, L, Shortt, N
BMJ open. 2020;(1):e031876
Abstract
INTRODUCTION Herpes simplex labialis (HSL) is a common infection that can cause painful lesions on the oral mucosa, commonly referred to as cold sores. Current biomedical treatments include topical aciclovir, which reduces the episode duration by an average of 0.5 days. This study will examine the efficacy and tolerability of an over-the-counter topical treatment, Dynamiclear in reducing duration and severity of HSL episodes. METHODS AND ANALYSIS This prospective, randomised, double-blind, placebo-controlled, multi-centre trial will recruit a minimum of 292 adult participants across Australia and New Zealand who present with a cold sore within 48 hours of onset. They will be randomly allocated in a 2:1 ratio to receive either topical Dynamiclear (active) or placebo. Dynamiclear's active ingredients are Hypericum perforatum, Calendula Officinalis and copper sulfate. A single topical treatment of active or placebo will be applied by a pharmacy-based investigator, and participants will be provided with a viral swab kit to confirm presence of herpes virus 1 or 2 from ulcerated lesions. Participants will receive reminders by email and/or SMS to complete an online daily diary assessing their cold sore lesion using a visual guide, and recording other symptoms on numeric scales until healed. The primary outcome variable is median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin. Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration. ETHICS AND DISSEMINATION Australian ethics approval from Western Sydney University Human Research Ethics Committee, ref: H12776. New Zealand Ethics approval from The Health and Disability Ethics Committees (HDEC) ref: 18/CEN/151. Results will be published in a peer-reviewed academic journal, presented at academic meetings and reported to participants TRIAL REGISTRATION NUMBERS Australia and New Zealand Clinical Trials Registry (ACTRN12618000890235); Universal Trial Number (UTN) (U1111-1233-2426).
-
2.
Improvements in Glycemic, Micronutrient, and Mineral Indices in Arab Adults with Pre-Diabetes Post-Lifestyle Modification Program.
Alfawaz, H, Naeef, AF, Wani, K, Khattak, MNK, Sabico, S, Alnaami, AM, Al-Daghri, NM
Nutrients. 2019;(11)
Abstract
The present study aimed to investigate the changes in dietary patterns of adult Saudis with prediabetes who underwent a six-month lifestyle modification program. A total of 160 Saudis with prediabetes (baseline fasting glucose 5.6-6.9 mmol/L), aged 20-60 years, were enrolled in one of the two arms: A one-time general advice about lifestyle modification (GA group) at orientation or a well-structured and monitored nutrition and lifestyle counseling for six months (guidance group). Fasting blood samples and a dietary recall for daily intakes of macro/micronutrients using a validated computerized food database "ESHA-the Food Processor Nutrition Analysis program" were collected pre- and post-intervention. Compliance to reference daily intake (RDI) was also calculated at both time points. At baseline, overall, severe deficiencies in the majority of micronutrient intakes were observed. Post intervention, clinically significant improvements in the glycemic indices (fasting glucose and insulin resistance) were seen over time in the guidance group. Also, significant improvements in dietary habits and physical activity levels were more apparent in the guidance group than the GA group, particularly in the daily intakes of total carbohydrate (46.9% compliance post vs. 20.3% at baseline); dietary fiber (21.9% vs. 3.1%); and some micronutrients like vitamin B6 (21.3% vs. 6.7%), vitamin B12 (45.3% vs. 28%), vitamin C (21.9% vs. 7.8%), riboflavin (40% vs. 10.7%), niacin (41.3% vs. 14.7%), magnesium (18.8% vs. 4.7%), iron (54.7% vs. 34.4%), and copper (37.3% vs. 13.3%). The study highlights the effects of a six-month lifestyle modification program in improving dietary micronutrient intakes of Saudis with prediabetes. Since micronutrient intake was observed to be low, fortification of these micronutrients in the Saudi diet is recommended.
-
3.
Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).
Issa, OM, Roberts, R, Mark, DB, Boineau, R, Goertz, C, Rosenberg, Y, Lewis, EF, Guarneri, E, Drisko, J, Magaziner, A, et al
American heart journal. 2018;:70-77
-
-
Free full text
-
Abstract
IMPORTANCE In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials. OBJECTIVE To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. DESIGN TACT was a factorial trial testing chelation treatments and a 28-component high-dose oral multivitamins and multiminerals regimen versus placebo in post-myocardial infarction (MI) patients 50 years or older. PARTICIPANTS There were 460 (27%) of 1,708 TACT participants not taking statins at baseline, 224 (49%) were in the active vitamin group and 236 (51%) were in the placebo group. SETTING Patients were enrolled at 134 sites around the United States and Canada. INTERVENTION Daily high-dose oral multivitamins and multiminerals (6 tablets, active or placebo). MAIN OUTCOME The primary end point of TACT was time to the first occurrence of any component of the composite end point: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina. RESULTS The primary end point occurred in 137 nonstatin participants (30%), of which 51 (23%) of 224 were in the active group and 86 (36%) of 236 were taking placebo (hazard ratio, 0.62; 95% confidence interval, 0.44-0.87; P=.006). Results in the key TACT secondary end point, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (hazard ratio, 0.46; 95% confidence interval, 0.28-0.75; P=.002). Multiple end point analyses were consistent with these results. CONCLUSION AND RELEVANCE High-dose oral multivitamin and multimineral supplementation seem to decrease combined cardiac events in a stable, post-MI population not taking statin therapy at baseline. These unexpected findings are being retested in the ongoing TACT2.
-
4.
Microcomputed Tomography Evaluation of Dentine Mineral Concentration in Primary Molars Managed by Three Treatment Protocols.
Mijan, MC, Frencken, JE, Schwass, DR, Chaves, SB, Leal, SC
Caries research. 2018;(4):303-311
Abstract
The objectives of the study were to quantify the dentine mineral concentration (DMC) in teeth restored conventionally, according to the atraumatic restorative treatment (ART) and ultraconservative (UCT) protocols (open cavities and small ART restorations), and the DMC underneath the open cavities of teeth managed by UCT versus nontreated, open cavities. We studied 50 teeth with restorations/open cavities, 39 restored teeth (9 by conventional restorative treatment [CRT], 17 by ART, and 13 by UCT) and 16 teeth with open cavities. Each restoration/open cavity was scanned using microcomputed tomography, with 3 hydroxyapatite disks with respective densities of 1.24, 1.33, and 1.57 g/cm3 as a reference. Images were reconstructed and the greyscale images were converted into DMC values. For each restoration/open cavity, 15 measurements of dentine immediately underneath and from the corresponding area in sound dentine were taken. DMC was expressed as a percentage of the DMC of sound dentine. ANOVA and the Student t test were used for statistical analysis. The mean DMC underneath restorations of the ART protocol group (98.93%) was statistically significantly higher than that of the UCT protocol group (91.98%), but not of the CRT protocol group (91.33%). On multiple surfaces, mean DMC in the axial area (94.32%) was statistically significantly higher than in the gingival area (92.80%). The mean DMC of open cavities managed by UCT protocol (89.05%) was statistically significantly higher than in nontreated open cavities (83.90%). In conclusion, a dentine-hypermineralized area underneath ART restorations was observed. Managing open cavities with a toothbrush and fluoride toothpaste (the UCT protocol) resulted in higher mineralized dentine underneath the cavity than in nontreated open cavities.
-
5.
COSMOS Project: Hemodialysis scenario in Europe.
Cannata-Andía, JB, Fernández Martín, JL
Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia. 2016;(4):381-8
-
6.
Variations in oral vitamin and mineral supplementation following bariatric gastric bypass surgery: a national survey.
Dunstan, MJ, Molena, EJ, Ratnasingham, K, Kamocka, A, Smith, NC, Humadi, S, Irukulla, S
Obesity surgery. 2015;(4):648-55
Abstract
BACKGROUND Bariatric surgery (including gastric bypass) is associated with long-term deficiencies in vitamins and minerals, which may have deleterious effects on physiology. The American Association of Clinical Endocrinologists' (AACE) guidelines regarding post-operative vitamin supplementation have recently been endorsed by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Supplements have cost implications. Non-branded multivitamins may have similar compositions to branded multivitamins, but at a lower cost. This study assesses multivitamin supplementation following bariatric gastric bypass in England against AACE guidelines. It also examines the composition and cost of branded and non-branded multivitamins. METHODS Micronutrient amounts in common multivitamin preparations were obtained from product literature. Costs were collected from a standard retailer. To determine vitamin prescribing patterns, the 37 NHS hospitals performing bariatric gastric bypasses in England were contacted. Practice was assessed against AACE guidelines. RESULTS All non-branded multivitamins met AACE guidelines for composition. Most had similar compositions to branded multivitamins, and all were cheaper. There was no standard practice regarding post-operative supplementation among the 35 responding hospitals. Only 7/35 (20%) hospitals followed the guidance for two-tablet doses of multivitamins. Immediately post-operatively, 25/35 (71%) hospitals administered calcium carbonate and vitamin D (none recommended calcium citrate, as recommended by AACE to improve absorption), and only 9/35 (26%) hospitals recommended iron to all patients. CONCLUSION Most non-branded multivitamins are lower cost alternatives to branded multivitamins, with similar compositions. The AACE recommendation for two-tablet doses of multivitamins is not being met by most English centres. Calcium and iron supplementation is also inadequate.
-
7.
EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy.
Lamas, GA, Boineau, R, Goertz, C, Mark, DB, Rosenberg, Y, Stylianou, M, Rozema, T, Nahin, RL, Terry Chappell, L, Lindblad, L, et al
American heart journal. 2014;(1):37-44.e5
-
-
Free full text
-
Abstract
BACKGROUND Disodium ethylenediaminetetraacetic acid (EDTA) reduced adverse cardiac outcomes in a factorial trial also testing oral vitamins. This report describes the intent-to-treat comparison of the 4 factorial groups overall and in patients with diabetes. METHODS This was a double-blind, placebo-controlled, 2 × 2 factorial multicenter randomized trial of 1,708 post-myocardial infarction (MI) patients ≥50 years of age and with creatinine ≤2.0 mg/dL randomized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo. The primary end point was a composite of total mortality, MI, stroke, coronary revascularization, or hospitalization for angina. RESULTS Median age was 65 years, 18% were female, 94% were Caucasian, 37% were diabetic, 83% had prior coronary revascularization, and 73% were on statins. Five-year Kaplan-Meier estimates for the primary end point was 31.9% in the chelation + high-dose vitamin group, 33.7% in the chelation + placebo vitamin group, 36.6% in the placebo infusion + active vitamin group, and 40.2% in the placebo infusions + placebo vitamin group. The reduction in primary end point by double active treatment compared with double placebo was significant (hazard ratio 0.74, 95% CI 0.57-0.95, P = .016). In patients with diabetes, the primary end point reduction of double active compared with double placebo was more pronounced (hazard ratio 0.49, 95% CI 0.33-0.75, P < .001). CONCLUSIONS In stable post-MI patients on evidence-based medical therapy, the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance.
-
8.
Cinacalcet and achievement of the NKF/K-DOQI recommended target values for bone and mineral metabolism in real-world clinical practice--the ECHO observational study.
Ureña, P, Jacobson, SH, Zitt, E, Vervloet, M, Malberti, F, Ashman, N, Leavey, S, Rix, M, Os, I, Saha, H, et al
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2009;(9):2852-9
Abstract
BACKGROUND The use and effectiveness of cinacalcet in 'real-world' clinical practice was investigated in a pan-European observational study in dialysis patients with secondary hyperparathyroidism (SHPT) of varying severity. METHODS Adult patients with chronic kidney disease on dialysis who had initiated cinacalcet treatment were enrolled. Data were collected 6 months before initiating cinacalcet, at baseline (initiation of cinacalcet) and up to 12 months after cinacalcet initiation. RESULTS A total of 1865 patients [mean (SD) age 58 (15) years] were enrolled from 187 sites in 12 countries. Most patients had a dialysis vintage of > or =1 year (1-5 years, n = 833; >5 years, n = 748 versus <1 year, n = 265). The patients generally had severely uncontrolled intact parathyroid hormone (iPTH) serum levels (median 721 pg/ml) and elevated phosphorus (median 5.9 mg/dl) and calcium (median 9.6 mg/dl) at baseline, despite being prescribed conventional therapies. The proportions of patients achieving the recommended [NKF-K/DOQI(TM) (KDOQI(TM))] targets increased from baseline [4%, 39%, 40% and 46% for iPTH, phosphorus, calcium and calcium-phosphorus product (Ca x P), respectively] to Month 12 (28%, 48%, 51% and 68%, respectively). At Month 12, 18% of patients had achieved the combined target for iPTH + Ca x P compared with 2% at baseline. Most patients (65%) received <60 mg/day cinacalcet at Month 12. Vitamin D sterol use remained fairly stable throughout the study. There was a 13% decrease in prescribed sevelamer; use of calcium-based phosphate binders increased by 5.6%. There was no unexpected safety or tolerability concerns. CONCLUSION This analysis of current European clinical practice shows that-consistent with findings from randomized controlled trials and retrospective observational studies-cinacalcet improves attainment of KDOQI bone metabolism targets in dialysis patients with various stages of SHPT.
-
9.
Effect of zinc supplementation on respiratory tract infections in children with cystic fibrosis.
Abdulhamid, I, Beck, FW, Millard, S, Chen, X, Prasad, A
Pediatric pulmonology. 2008;(3):281-7
-
-
Free full text
-
Abstract
Zinc (Zn) has significant anti-oxidant and anti-inflammatory activity. Zn deficiency can occur in subsets of patients with cystic fibrosis (CF) especially those with malabsorption and impaired growth. Although supplemental Zn has significantly reduced infections in various disorders, its efficacy has not been thoroughly investigated in CF. We performed a double blind placebo controlled pilot study to investigate the effect of daily 30 mg elemental Zn for 1 year on the rate of respiratory tract infections (RTIs), use of antibiotics and plasma cytokines in 26 children with CF (ages 7-18 years). Plasma Zn, Cu, inflammatory cytokines and ex vivo generation of IL-2 were measured at baseline and at the end of the study. The number of days of oral antibiotics was lower in Zn treated patients compared to placebo (P = 0.05). However, compared to placebo, the effect of Zn was greater in patients who exhibited low plasma Zn at baseline (P = 0.02) than those who had plasma Zn levels identical to normal subjects (P = 0.55). Zn supplementation was marginally effective in reducing percentage increase in plasma IL-6 and IL-8 while increasing the percentage change in ex vivo generation of IL-2 in isolated mononuclear cell. In conclusion, oral intake of 30 mg/day of Zn reduced the number of days of oral antibiotics used to treat RTIs in children with CF. A higher daily Zn dose may be needed to decrease RTIs and modify immune responses.
-
10.
Effects of lowering dialysate calcium concentration on mineral metabolism and parathyroid hormone secretion: a multicentric study.
Lezaic, V, Pejanovic, S, Kostic, S, Pljesa, S, Dimkovic, N, Komadina, L, Jovanovic, D, Marinkovic, J, Djukanovic, L
Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy. 2007;(2):121-30
Abstract
This prospective study was conducted with the aim of examining the efficacy of lowering dialysate calcium (dCa) in order to: (i) stimulate bone turnover in hemodialysis patients with biochemical signs of adynamic bone disease (ABD) (hypercalcemia, normal alkaline phosphatase and intact parathyroid hormone (iPTH) <150 pg/mL); and (ii) diminish hypercalcemia in patients with secondary hyperparathyroidism (sHPT) (hypercalcemia, high alkaline phosphatase and iPTH > 400 pg/mL), thus permitting the use of calcium-containing phosphorus binders and vitamin D metabolites. Patients were divided into: an ABD-treated group (24 patients), a sHPT-treated group (18 patients), an ABD-control group (12 patients) and a sHPT-control group (11 patients). For the ABD- and sHPT-treated patients, hemodialysis was conducted with dCa 1.5 mmol/L for three months and then with dCa 1.25 mmol/L for an additional three months, while in the control groups hemodialysis was conducted with dCa 1.75 mmol/L during the entire study. Reduction of dCa in patients with ABD caused a slight but insignificant decrease of Ca, but a significant and permanent increase of bone-specific alkaline phosphatase and intact parathyroid hormone level serum levels. Reduction of dCa in patients with sHPT slightly but insignificantly decreased Ca and intact parathyroid hormone level values. Nevertheless, this enabled the calcium-based phosphate binder dose to be raised and vitamin D3 metabolites to be introduced. Logistic regression analysis indicated that milder bone disease (both ABD and sHPT) was associated with more the favorable effect of dCa reduction. Thus, low dCa stimulated parathyroid glands and increased bone turnover in ABD patients, and enabled better control of mineral metabolism in sHPT patients.