PLoS clinical trials最新文献

{"title":"A randomized controlled trial of folate supplementation when treating malaria in pregnancy with sulfadoxine-pyrimethamine.","authors":"Peter Ouma,&nbsp;Monica E Parise,&nbsp;Mary J Hamel,&nbsp;Feiko O Ter Kuile,&nbsp;Kephas Otieno,&nbsp;John G Ayisi,&nbsp;Piet A Kager,&nbsp;Richard W Steketee,&nbsp;Laurence Slutsker,&nbsp;Anna M van Eijk","doi":"10.1371/journal.pctr.0010028","DOIUrl":"10.1371/journal.pctr.0010028","url":null,"abstract":"<p><strong>Objectives: </strong>Sulfadoxine-pyrimethamine (SP) is an antimalarial drug that acts on the folate metabolism of the malaria parasite. We investigated whether folate (FA) supplementation in a high or a low dose affects the efficacy of SP for the treatment of uncomplicated malaria in pregnant women.</p><p><strong>Design: </strong>This was a randomized, placebo-controlled, double-blind trial.</p><p><strong>Setting: </strong>The trial was carried out at three hospitals in western Kenya.</p><p><strong>Participants: </strong>The participants were 488 pregnant women presenting at their first antenatal visit with uncomplicated malaria parasitaemia (density of >or= 500 parasites/microl), a haemoglobin level higher than 7 g/dl, a gestational age between 17 and 34 weeks, and no history of antimalarial or FA use, or sulfa allergy. A total of 415 women completed the study.</p><p><strong>Interventions: </strong>All participants received SP and iron supplementation. They were randomized to the following arms: FA 5 mg, FA 0.4 mg, or FA placebo. After 14 days, all participants continued with FA 5 mg daily as per national guidelines. Participants were followed at days 2, 3, 7, 14, 21, and 28 or until treatment failure.</p><p><strong>Outcome measures: </strong>The outcomes were SP failure rate and change in haemoglobin at day 14.</p><p><strong>Results: </strong>The proportion of treatment failure at day 14 was 13.9% (19/137) in the placebo group, 14.5% (20/138) in the FA 0.4 mg arm (adjusted hazard ratio [AHR], 1.07; 98.7% confidence interval [CI], 0.48 to 2.37; p = 0.8), and 27.1% (38/140) in the FA 5 mg arm (AHR, 2.19; 98.7% CI, 1.09 to 4.40; p = 0.005). The haemoglobin levels at day 14 were not different relative to placebo (mean difference for FA 5 mg, 0.17 g/dl; 98.7% CI, -0.19 to 0.52; and for FA 0.4 mg, 0.14 g/dl; 98.7% CI, -0.21 to 0.49).</p><p><strong>Conclusions: </strong>Concomitant use of 5 mg FA supplementation compromises the efficacy of SP for the treatment of uncomplicated malaria in pregnant women. Countries that use SP for treatment or prevention of malaria in pregnancy need to evaluate their antenatal policy on timing or dose of FA supplementation.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010028","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26319857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Three steps to protecting pediatric research participants from excessive risks.","authors":"David Wendler","doi":"10.1371/journal.pctr.0010025","DOIUrl":"10.1371/journal.pctr.0010025","url":null,"abstract":"There is growing recognition that pediatric research is needed to improve pediatric medicine [1,2]. Research guidelines try to accommodate this need by allowing children to be enrolled in research when it offers an appropriate risk–benefit profile. These guidelines allow children to undergo research interventions that offer a compensating potential for clinical benefit. Most guidelines also allow children to undergo research interventions that do not offer a compensating potential for clinical benefit, provided the risks are acceptably low. \u0000 \u0000To implement this threshold on acceptable risks, review committees, known variously as ethics review committees, institutional review boards, or research ethics committees (RECs), must make three related assessments. They must identify the research interventions included in the study under review, determine which, if any, of the research interventions fail to offer participants a compensating potential for clinical benefit, and ensure that these interventions do not pose excessive risks. \u0000 \u0000These steps, while vital to protecting pediatric participants from excessive risks, have not been systematically described. This essay attempts to address this gap by describing the assessment appropriate for each of these three steps.","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010025","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26287396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of physical inactivity on the oxidation of saturated and monounsaturated dietary Fatty acids: results of a randomized trial.","authors":"Audrey Bergouignan,&nbsp;Dale A Schoeller,&nbsp;Sylvie Normand,&nbsp;Guillemette Gauquelin-Koch,&nbsp;Martine Laville,&nbsp;Timothy Shriver,&nbsp;Michel Desage,&nbsp;Yvon Le Maho,&nbsp;Hiroshi Ohshima,&nbsp;Claude Gharib,&nbsp;Stéphane Blanc","doi":"10.1371/journal.pctr.0010027","DOIUrl":"https://doi.org/10.1371/journal.pctr.0010027","url":null,"abstract":"<p><strong>Objectives: </strong>Changes in the way dietary fat is metabolized can be considered causative in obesity. The role of sedentary behavior in this defect has not been determined. We hypothesized that physical inactivity partitions dietary fats toward storage and that a resistance exercise training program mitigates storage.</p><p><strong>Design: </strong>We used bed rest, with randomization to resistance training, as a model of physical inactivity.</p><p><strong>Setting: </strong>The trial took place at the Space Clinic (Toulouse, France).</p><p><strong>Participants: </strong>A total of 18 healthy male volunteers, of mean age +/- standard deviation 32.6 +/- 4.0 y and body mass index 23.6 +/- 0.7 kg/m(2), were enrolled.</p><p><strong>Interventions: </strong>An initial 15 d of baseline data collection were followed by 3 mo of strict bed-rest alone (control group, n = 9) or with the addition of supine resistance exercise training every 3 d (exercise group, n = 9).</p><p><strong>Outcome measures: </strong>Oxidation of labeled [d(31)]palmitate (the main saturated fatty acid of human diet) and [1-(13)C]oleate (the main monounsaturated fatty acid), body composition, net substrate use, and plasma hormones and metabolites were measured.</p><p><strong>Results: </strong>Between-group comparisons showed that exercise training did not affect oxidation of both oleate (mean difference 5.6%; 95% confidence interval [95% CI], -3.3% to 14.5%; p = 0.20) and palmitate (mean difference -0.2%; 95% CI, -4.1% to 3.6%; p = 0.89). Within-group comparisons, however, showed that inactivity changed oxidation of palmitate in the control group by -11.0% (95% CI, -19.0% to -2.9%; p = 0.01) and in the exercise group by -11.3% (95% CI, -18.4% to -4.2%; p = 0.008). In contrast, bed rest did not significantly affect oleate oxidation within groups. In the control group, the mean difference in oleate oxidation was 3.2% (95% CI, -4.2% to 10.5%; p = 0.34) and 6.8% (95% CI, -1.2% to 14.7%; p = 0.08) in the exercise group.</p><p><strong>Conclusions: </strong>Independent of changes in energy balance (intake and/or output), physical inactivity decreased the oxidation of saturated but not monounsaturated dietary fat. The effect is apparently not compensated by resistance exercise training. These results suggest that Mediterranean diets should be recommended in sedentary subjects and recumbent patients.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010027","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26287885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of cyclooxygenase inhibitors in the Women's Health Initiative hormone trials: secondary analysis of a randomized trial.","authors":"Judith Hsia,&nbsp;Joann E Manson,&nbsp;Lewis Kuller,&nbsp;Mary Pettinger,&nbsp;John H Choe,&nbsp;Robert D Langer,&nbsp;Marian Limacher,&nbsp;Albert Oberman,&nbsp;Judith Ockene,&nbsp;Mary Jo O'Sullivan,&nbsp;Jennifer G Robinson","doi":"10.1371/journal.pctr.0010026","DOIUrl":"https://doi.org/10.1371/journal.pctr.0010026","url":null,"abstract":"<p><strong>Objectives: </strong>We evaluated the hypothesis that cyclooxygenase (COX) inhibitor use might have counteracted a beneficial effect of postmenopausal hormone therapy, and account for the absence of cardioprotection in the Women's Health Initiative hormone trials. Estrogen increases COX expression, and inhibitors of COX such as nonsteroidal anti-inflammatory agents appear to increase coronary risk, raising the possibility of a clinically important interaction in the trials.</p><p><strong>Design: </strong>The hormone trials were randomized, double-blind, and placebo-controlled. Use of nonsteroidal anti-inflammatory drugs was assessed at baseline and at years 1, 3, and 6.</p><p><strong>Setting: </strong>The Women's Health Initiative hormone trials were conducted at 40 clinical sites in the United States.</p><p><strong>Participants: </strong>The trials enrolled 27,347 postmenopausal women, aged 50-79 y.</p><p><strong>Interventions: </strong>We randomized 16,608 women with intact uterus to conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily or to placebo, and 10,739 women with prior hysterectomy to conjugated estrogens 0.625 mg daily or placebo.</p><p><strong>Outcome measures: </strong>Myocardial infarction, coronary death, and coronary revascularization were ascertained during 5.6 y of follow-up in the estrogen plus progestin trial and 6.8 y of follow-up in the estrogen alone trial.</p><p><strong>Results: </strong>Hazard ratios with 95% confidence intervals were calculated from Cox proportional hazard models stratified by COX inhibitor use. The hazard ratio for myocardial infarction/coronary death with estrogen plus progestin was 1.13 (95% confidence interval 0.68-1.89) among non-users of COX inhibitors, and 1.35 (95% confidence interval 0.86-2.10) among continuous users. The hazard ratio with estrogen alone was 0.92 (95% confidence interval 0.57-1.48) among non-users of COX inhibitors, and 1.08 (95% confidence interval 0.69-1.70) among continuous users. In a second analytic approach, hazard ratios were calculated from Cox models that included hormone trial assignment as well as a time-dependent covariate for medication use, and an interaction term. No significant interaction was identified.</p><p><strong>Conclusions: </strong>Use of COX inhibitors did not significantly affect the Women's Health Initiative hormone trial results.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010026","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26287397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effects on saturated fat purchases of providing internet shoppers with purchase- specific dietary advice: a randomised trial.","authors":"Amy Huang,&nbsp;Federica Barzi,&nbsp;Rachel Huxley,&nbsp;Gareth Denyer,&nbsp;Beth Rohrlach,&nbsp;Kathy Jayne,&nbsp;Bruce Neal","doi":"10.1371/journal.pctr.0010022","DOIUrl":"https://doi.org/10.1371/journal.pctr.0010022","url":null,"abstract":"<p><strong>Objectives: </strong>The supermarket industry now services many customers through online food shopping over the Internet. The Internet shopping process offers a novel opportunity for the modification of dietary patterns. The aim of this study was to evaluate the effects on consumers' purchases of saturated fat of a fully automated computerised system that provided real-time advice tailored to the consumers' specific purchases recommending foods lower in saturated fat.</p><p><strong>Design: </strong>This study was a blinded, randomised controlled trial.</p><p><strong>Setting: </strong>The study was conducted in Sydney, New South Wales, Australia.</p><p><strong>Participants: </strong>The participants were consumers using a commercial online Internet shopping site between February and June 2004.</p><p><strong>Interventions: </strong>Individuals assigned to intervention received fully automated advice that recommended specific switches from selected products higher in saturated fat to alternate similar products lower in saturated fat. Participants assigned to control received general non-specific advice about how to eat a diet lower in saturated fat.</p><p><strong>Outcome measures: </strong>The outcome measure was the difference in saturated fat (grams per 100 g of food) in shopping baskets between the intervention and control groups.</p><p><strong>Results: </strong>There were 497 randomised participants, mean age 40 y, each shopping for an average of about three people. The amount of saturated fat in the foods purchased by the intervention group was 0.66% lower (95% confidence interval 0.48-0.84, p < 0.001) than in the control group. The effects of the intervention were sustained over consecutive shopping episodes, and there was no difference in the average cost of the food bought by each group.</p><p><strong>Conclusions: </strong>Fully automated, purchase-specific dietary advice offered to customers during Internet shopping can bring about changes in food purchasing habits that are likely to have significant public health implications. Because implementation is simple to initiate and maintain, this strategy would likely be highly cost-effective.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010022","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26285539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fluid resuscitation in malaria: the need for new randomised clinical trials.","authors":"Nick Day","doi":"10.1371/journal.pctr.0010024","DOIUrl":"https://doi.org/10.1371/journal.pctr.0010024","url":null,"abstract":"Very little clinical research has been conducted on how to manage children with severemalaria, despite it accounting for the deaths of around 1 million children each year in Africa alone. Antimalarial drugs remain the mainstay of treatment (and are the subject of several current or planned clinical trials), but there is increasing debate around aspects of supportive care and the treatment of complications. No aspect of care has been more controversial in recent years than the initial fluid management of children with severe malaria, particularly given the resourcepoor health-care context in which most such children are treated. The debate centres around the role of hypovolaemia (i.e., insufficient circulating blood volume) in the pathophysiology of severe malaria. Hypovolaemia has been incriminated as an important cause of metabolic acidosis, which has been shown repeatedly to be associated with a poor prognosis. The key question is whether hypovolaemia contributes to impaired tissue perfusion in severe malaria, contributing to the anaerobic glycolysis and consequent acidosis. Some studies of severe malaria in children have supported this hypothesis by providing indirect evidence (e.g., capillary refill time, central venous p r e s s u r e mea su r emen t s , r a i s e d creatinine, and clinical dehydration) that severely ill patients are commonly hypovolaemic on admission, and that this contributes to the severity of the disease [1,2]. In febrile children hypovolaemia often results from dehydration, but a detailed study in Gabon showed that the children with severe malaria investigated had only a mild or moderate degree of dehydration (as measured by total body water, not necessarily synonymous with hypovolaemia) [3]. So, should children with severe malaria all receive rapid intravenous fluid rehydration? And if so, with what fluid? Proponents of rapid fluid repletion cite the standards of care applied in resourcerich settings for severely ill children with bacterial sepsis, whilst those advocating caution argue that malaria should be considered differently, particularly given the haemodynamic and circulatory differences from sepsis and the concerns of precipitating or worsening pulmonary or cerebral oedema [2,4]. It is clear that clinical trials are the only way forward to resolve the debate. There have been several previously published intervention studies, all conducted by Maitland and the Kilifi team on the Kenyan coast, but to date all have been too small and heterogenous to provide conclusive answers.","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010024","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26272341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Volume expansion with albumin compared to gelofusine in children with severe malaria: results of a controlled trial.","authors":"Samuel Akech, Samson Gwer, Richard Idro, Greg Fegan, Alice C Eziefula, Charles R J C Newton, Michael Levin, Kathryn Maitland","doi":"10.1371/journal.pctr.0010021","DOIUrl":"10.1371/journal.pctr.0010021","url":null,"abstract":"<p><strong>Objectives: </strong>Previous studies have shown that in children with severe malaria, resuscitation with albumin infusion results in a lower mortality than resuscitation with saline infusion. Whether the apparent benefit of albumin is due solely to its colloidal properties, and thus might also be achieved with other synthetic colloids, or due to the many other unique physiological properties of albumin is unknown. As albumin is costly and not readily available in Africa, examination of more affordable colloids is warranted. In order to inform the design of definitive phase III trials we compared volume expansion with Gelofusine (succinylated modified fluid gelatin 4% intravenous infusion) with albumin.</p><p><strong>Design: </strong>This study was a phase II safety and efficacy study.</p><p><strong>Setting: </strong>The study was conducted at Kilifi District Hospital, Kenya.</p><p><strong>Participants: </strong>The participants were children admitted with severe falciparum malaria (impaired consciousness or deep breathing), metabolic acidosis (base deficit > 8 mmol/l), and clinical features of shock.</p><p><strong>Interventions: </strong>The interventions were volume resuscitation with either 4.5% human albumin solution or Gelofusine.</p><p><strong>Outcome measures: </strong>Primary endpoints were the resolution of shock and acidosis; secondary endpoints were in-hospital mortality and adverse events including neurological sequelae.</p><p><strong>Results: </strong>A total of 88 children were enrolled: 44 received Gelofusine and 44 received albumin. There was no significant difference in the resolution of shock or acidosis between the groups. Whilst no participant developed pulmonary oedema or fluid overload, fatal neurological events were more common in the group receiving gelatin-based intervention fluids. Mortality was lower in patients receiving albumin (1/44; 2.3%) than in those treated with Gelofusine (7/44; 16%) by intention to treat (Fisher's exact test, p = 0.06), or 1/40 (2.5%) and 4/40 (10%), respectively, for those treated per protocol (p = 0.36). Meta-analysis of published trials to provide a summary estimate of the effect of albumin on mortality showed a pooled relative risk of death with albumin administration of 0.19 (95% confidence interval 0.06-0.59; p = 0.004 compared to other fluid boluses).</p><p><strong>Conclusions: </strong>In children with severe malaria, we have shown a consistent survival benefit of receiving albumin infusion compared to other resuscitation fluids, despite comparable effects on the resolution of acidosis and shock. The lack of similar mortality benefit from Gelofusine suggests that the mechanism may involve a specific neuroprotective effect of albumin, rather than solely the effect of the administered colloid. Further exploration of the benefits of albumin is warranted in larger clinical trials.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1569382/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26272342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gametocytaemia after drug treatment of asymptomatic Plasmodium falciparum.","authors":"Samuel Dunyo, Paul Milligan, Tansy Edwards, Colin Sutherland, Geoffrey Targett, Margaret Pinder","doi":"10.1371/journal.pctr.0010020","DOIUrl":"10.1371/journal.pctr.0010020","url":null,"abstract":"<p><strong>Objectives: </strong>Treatment of Plasmodium falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the prevalence and density of gametocytes. We did a randomized trial to determine the effect of treatment of asymptomatic infections with SP or SP plus one dose of artesunate (SP+AS) on gametocyte carriage.</p><p><strong>Design: </strong>The study was a three-arm open-label randomized trial. We randomized asymptomatic carriers of P. falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 mo.</p><p><strong>Setting: </strong>The trial was conducted during the dry (low malaria transmission) season in four rural villages in Gambia.</p><p><strong>Participants: </strong>Participants were adults and children aged over 6 mo with asexual P. falciparum infection and confirmed free of clinical symptoms of malaria over a 2-d screening period.</p><p><strong>Interventions: </strong>Participants were randomized to receive a single dose of SP or SP+AS or placebo.</p><p><strong>Outcome measures: </strong>The outcome measures were the presence of gametocytes 7 and 56 d after treatment, and the duration and density of gametocytaemia over 2 mo.</p><p><strong>Results: </strong>In total, 372 asymptomatic carriers were randomized. Gametocyte prevalence on day 7 was 10.5% in the placebo group, 11.2% in the SP group (risk difference to placebo 0.7%, 95% confidence interval -7.4% to 8.7%, p = 0.87), and 7.1% in the SP+AS group (risk difference to placebo 4.1%, 95% confidence interval -3.3% to 12%, p = 0.28). By day 56, gametocyte prevalence was 13% in the placebo group and 2% in both drug-treated groups. Gametocyte carriage (the area under the curve of gametocyte density versus time), was reduced by 71% in the SP group, and by 74% in the SP+AS group, compared to placebo. Gametocyte carriage varied with age and was greater among children under 15 than among adults.</p><p><strong>Conclusions: </strong>Treatment of asymptomatic carriers of P. falciparum with SP does not increase gametocyte carriage or density. Effective treatment of asexual parasitaemia in the dry season reduces gametocyte carriage to very low levels after 4 wk.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1851719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26285541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term impact of malaria chemoprophylaxis on cognitive abilities and educational attainment: follow-up of a controlled trial.","authors":"Matthew C H Jukes,&nbsp;Margaret Pinder,&nbsp;Elena L Grigorenko,&nbsp;Helen Baños Smith,&nbsp;Gijs Walraven,&nbsp;Elisa Meier Bariau,&nbsp;Robert J Sternberg,&nbsp;Lesley J Drake,&nbsp;Paul Milligan,&nbsp;Yin Bun Cheung,&nbsp;Brian M Greenwood,&nbsp;Donald A P Bundy","doi":"10.1371/journal.pctr.0010019","DOIUrl":"https://doi.org/10.1371/journal.pctr.0010019","url":null,"abstract":"<p><strong>Objectives: </strong>We investigated the long-term impact of early childhood malaria prophylaxis on cognitive and educational outcomes.</p><p><strong>Design: </strong>This was a household-based cluster-controlled intervention trial.</p><p><strong>Setting: </strong>The study was conducted in 15 villages situated between 32 km to the east and 22 km to the west of the town of Farafenni, the Gambia, on the north bank of the River Gambia.</p><p><strong>Participants: </strong>A total of 1,190 children aged 3-59 mo took part in the trial. We traced 579 trial participants (291 in the prophylaxis group and 288 in the placebo group) in 2001, when their median age was 17 y 1 mo (range 14 y 9 mo to 19 y 6 mo).</p><p><strong>Interventions: </strong>Participants received malaria chemoprophylaxis (dapsone/pyrimethamine) or placebo for between one and three malaria transmission seasons from 1985 to 1987 during the controlled trial. At the end of the trial, prophylaxis was provided for all children under 5 y of age living in the study villages.</p><p><strong>Outcome measures: </strong>The outcome measures were cognitive abilities, school enrolment, and educational attainment (highest grade reached at school).</p><p><strong>Results: </strong>There was no significant overall intervention effect on cognitive abilities, but there was a significant interaction between intervention group and the duration of post-trial prophylaxis (p = 0.034), with cognitive ability somewhat higher in the intervention group among children who received no post-trial prophylaxis (treatment effect = 0.2 standard deviations [SD], 95% confidence interval [CI] -0.03 to 0.5) and among children who received less than 1 y of post-trial prophylaxis (treatment effect = 0.4 SD, 95% CI 0.1 to 0.8). The intervention group had higher educational attainment by 0.52 grades (95% CI = -0.041 to 1.089; p = 0.069). School enrolment was similar in the two groups.</p><p><strong>Conclusions: </strong>The results are suggestive of a long-term effect of malaria prophylaxis on cognitive function and educational attainment, but confirmatory studies are needed.</p>","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010019","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26285540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Genetic Polymorphisms and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets","authors":"T. Sørensen, P. Boutin, Moira A. Taylor, L. Larsen, C. Verdich, L. Petersen, C. Holst, S. Echwald, C. Dina, S. Toubro, M. Petersen, J. Polák, K. Clément, J. Martínez, D. Langin, J. Oppert, V. Štich, I. Macdonald, P. Arner, W. Saris, O. Pedersen, A. Astrup, P. Froguel","doi":"10.1371/journal.pctr.0010023","DOIUrl":"https://doi.org/10.1371/journal.pctr.0010023","url":null,"abstract":"","PeriodicalId":87416,"journal":{"name":"PLoS clinical trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2006-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1371/journal.pctr.0010023","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66664347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}