OPUS School Meal Study
3 de março de 2017 atualizado por: Arne Astrup
OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study
The aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children.
The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
834
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Copenhagen, Dinamarca, 1958
- Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
8 anos a 11 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Pupils in 3rd and 4th grades
- Primary Schools in the Zealand Region and Capital Region of Denmark
- Schools with an available school kitchen, that can be approved by the food authorities
- Schools where at least 60 % of the pupils in three or more classes signs up to participate in the Study
Exclusion Criteria:
- The children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. This, however depends on the character of the other study.
- The children must not suffer from serious food allergies or food intolerance.
- The children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders
- The Schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: NewNordicDiet first
Intervention with NND for 3 mo then no intervention for 3 mo
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The study participants are provided with three daily school meals for 3 month
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Outro: NewNordicDiet last
No intervention for 3 mo and then intervention with NND for 3 mo
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The study participants are provided with three daily school meals for 3 month
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Metabolic syndrome score
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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The metabolic syndrome score is a continuous z-score based on individual z-scores for waist circumference (WC), mean arterial pressure (MAP), serum high density lipoprotein (HDL), Serum triglyceride (TG) and Homeostasis Model Assessment (HOMA) index.
It´s an internal score meaning that the basis for the score is the distribution of values in this study population at baseline.
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Change during 3 month of intervention compared with change during 3 month control period
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Concentration Performance
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Concentration Performance is assessed by means of a concentration test called the D2-test of Attention.
Concentration Performance is derived from the number of correctly crossed out relevant items minus the errors of commission (confused).
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Change during 3 month of intervention compared with change during 3 month control period
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Early Cardiovascular Risk Markers
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Systolic and diastolic blood pressure, serum blood cholesterol (total, Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL) and HDL) and TG, plasma glucose, serum insulin and the HOMA index.
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Change during 3 month of intervention compared with change during 3 month control period
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Other metabolic syndrome scores
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Other metabolic syndrome scores will be calculated as continuous z-scores based on each of the individual z-scores for Waist Circumference (WC), Mean Arterial Pressure (MAP), serum High Density Lipoprotein (HDL), serum Triglyceride (TG) and insulin, separately, and possibly with weighted contribution of each of the risk markers to the score.
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Change during 3 month of intervention compared with change during 3 month control period
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Inflammatory markers
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Plasma concentrations of the cytokines Interleucin-6 (IL-6) and Tumor Necrosis Factor (TNF) alfa, the adipokine adiponectin and the acute-phase protein c-reactive protein (CRP) (measured as high-sensitive) in plasma will be used as markers of subclinical inflammation and related to the other early metabolic syndrome and cardiovascular risk markers.
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Change during 3 month of intervention compared with change during 3 month control period
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Illnesses and use of medicine
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Self-reported data collected by computer-assisted questionnaire interview with the parents, either personal (month 0) or by telephone (month 3 and 6).
Outcomes are the number of days, during the last two weeks, with: asthma symptoms, use of asthma-medicine, hay-fever symptoms, use of hay-fever-medicine, atopic eczema, symptoms such as sore throat or fever, and the use of pain killers or antibiotics.
The number of days of absence from school due to illness, the number of days of illness during weekends and holidays, and number of visits to the doctor will also be evaluated.
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Change during 3 month of intervention compared with change during 3 month control period
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Use of ADHD medicine
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Among those children with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD), the mean daily dose of methylphenidate (based on reported intake of drugs containing this substance) during the last two weeks will be evaluated.
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Change during 3 month of intervention compared with change during 3 month control period
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General fatty acid composition of whole-blood
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.
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Change during 3 month of intervention compared with change during 3 month control period
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Reading proficiency
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Reading proficiency is assessed by means of the Danish Sentence Reading test 2 having two measures: Percentage of correct sentences read within eight minutes.
Reading speed - number of sentences reached.
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Change during 3 month of intervention compared with change during 3 month control period
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Mathematics proficiency
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Mathematics proficiency is assessed by means of the Danish MG test for 3rd and 4th grade.
They each have one measure: Number of correct results within 45 minutes.
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Change during 3 month of intervention compared with change during 3 month control period
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Learning
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Student learning is assessed by means of the Danish LRS Learning Rating Scale filled out by students.
The scale contains four subscales and one combined scale (sum score) adding the four subscales.
The subscales cover: academic learning, social situation in school, teaching style appropriateness, and school expectations.
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Change during 3 month of intervention compared with change during 3 month control period
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Wellness
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Student wellness is assessed by means of the Danish WRS Wellness Rating Scale filled out by students.
The scale contains five subscales and one combined scale (sum score) adding the five subscales.
The subscales cover: Living environment, school, school mates, family, and self concept.
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Change during 3 month of intervention compared with change during 3 month control period
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Physical activity
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Physical activity is measured using actigraphy. Outcome measures will be counts/min, time spent in sedentary, light, moderate and vigorous activities. Questions regarding TV-watching, playing with videogames and physical activity, will help identify activity-pattern. |
Change during 3 month of intervention compared with change during 3 month control period
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Sleep
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Sleep is measured using actigraphy with the monitor placed on the right hip for all students and on the non-dominant wrist for a sub-sample. Using a sleep diary, total sleep time and sleep efficiency will be derived from these actigraphy measurements. In addition, at month 0, the abbreviated version of the Children's Sleep Habits Questionnaire (CSHQ) is used to identify sleep problems. |
Change during 3 month of intervention compared with change during 3 month control period
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Fitness
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).
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Change during 3 month of intervention compared with change during 3 month control period
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Dietary intake
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Dietary intake is measured as micro-and macronutrients as well as food groups (e.g.
fish and fruit/vegetables) by means of a 7-day dietary survey, which is a web based recall record method developed especially for children.
Families without internet access can use a paper version of a 7-day dietary survey.
The meal time perception is measured as well.
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Change during 3 month of intervention compared with change during 3 month control period
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Body weight and body mass index (BMI)
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Body weight (in kg, BMI and BMI z-score calculated on the basis of the current references from the World Health Organization (WHO)
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Change during 3 month of intervention compared with change during 3 month control period
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Body composition
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Body composition will be determined by Dual energy X-ray Absorptiometry (DXA) scanning.
The parameters included are total body Fat Free Mass Index (FFMI in kg/m2), total body Fat Mass Index (FMI in kg/m2), total body fat percentage and the ratio between android and gynoid fat mass in kg.
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Change during 3 month of intervention compared with change during 3 month control period
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Appetite-regulating hormones
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Leptin and ghrelin.
If resources are available at the end of the study period, ghrelin will be separated in acylated and deacylated ghrelin, and both the effect of the intervention on total, acylated, deacylated and the ratio between acylated:deacylated ghrelin will be assessed.
If the resources are too tight at the end of the study, only total ghrelin will be used.
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Change during 3 month of intervention compared with change during 3 month control period
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Vitamin D status
Prazo: Baseline and change during 3 month of intervention compared with change during 3 month control period
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Serum concentrations of 25-hydroxyvitamin D [25(OH)D] will be used as marker of vitamin D status, related to food intake and time of season.
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Baseline and change during 3 month of intervention compared with change during 3 month control period
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Bone Health
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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Bone Health will be evaluated by DXA scanning (total body and spine Bone Mineral Content (BMC), Bone Mineral Density (BMD), and Bone Area (BA).
Osteocalcin and serum Parathyreoideahormon (PTH) are also included as markers of bone health.
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Change during 3 month of intervention compared with change during 3 month control period
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General fatty acid composition in whole-blood
Prazo: Change during 3 month intervnetion compared with change during 3 month control period
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Change during 3 month intervnetion compared with change during 3 month control period
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Iron status
Prazo: Change during 3 month intervention compared with 3 month control period
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Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
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Change during 3 month intervention compared with 3 month control period
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Attention - other measures
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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The following five measures from the attention test D2 will be used: TN=Total Number of items processed E%=Percentage of errors |
Change during 3 month of intervention compared with change during 3 month control period
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Omega-3 index in whole-blood
Prazo: Change during 3 month of intervention compared with change during 3 month control period
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The Omega-3 index in whole-blood is defined as the weight percentage of eicosapentaenoicacid + the weight percentage of docosahexaenoic acid in whole-blood
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Change during 3 month of intervention compared with change during 3 month control period
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Genotyping
Prazo: Baseline
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SNPs in genes related to metabolic pathways, messenger molecules, receptors or other genes that may affect efficacy measures in OPUS School Food Project
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Baseline
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Lauritzen L, Sorensen LB, Harslof LB, Ritz C, Stark KD, Astrup A, Dyssegaard CB, Egelund N, Michaelsen KF, Damsgaard CT. Mendelian randomization shows sex-specific associations between long-chain PUFA-related genotypes and cognitive performance in Danish schoolchildren. Am J Clin Nutr. 2017 Jul;106(1):88-95. doi: 10.3945/ajcn.117.152595. Epub 2017 May 17.
- Biltoft-Jensen A, Damsgaard CT, Andersen EW, Ygil KH, Andersen R, Ege M, Christensen T, Thorsen AV, Tetens I, Wu H, Landberg R. Validation of Reported Whole-Grain Intake from a Web-Based Dietary Record against Plasma Alkylresorcinol Concentrations in 8- to 11-Year-Olds Participating in a Randomized Controlled Trial. J Nutr. 2016 Feb;146(2):377-83. doi: 10.3945/jn.115.222620. Epub 2016 Jan 13.
- Sorensen LB, Dyssegaard CB, Damsgaard CT, Petersen RA, Dalskov SM, Hjorth MF, Andersen R, Tetens I, Ritz C, Astrup A, Lauritzen L, Michaelsen KF, Egelund N. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial. Br J Nutr. 2015 Apr 28;113(8):1280-91. doi: 10.1017/S0007114515000033. Epub 2015 Mar 20.
- Dalskov SM, Ritz C, Larnkjaer A, Damsgaard CT, Petersen RA, Sorensen LB, Ong KK, Astrup A, Molgaard C, Michaelsen KF. The role of leptin and other hormones related to bone metabolism and appetite regulation as determinants of gain in body fat and fat-free mass in 8-11-year-old children. J Clin Endocrinol Metab. 2015 Mar;100(3):1196-205. doi: 10.1210/jc.2014-3706. Epub 2014 Dec 22.
- Hjorth MF, Quist JS, Andersen R, Michaelsen KF, Tetens I, Astrup A, Chaput JP, Sjodin A. Change in sleep duration and proposed dietary risk factors for obesity in Danish school children. Pediatr Obes. 2014 Dec;9(6):e156-9. doi: 10.1111/ijpo.264. Epub 2014 Sep 24.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2011
Conclusão Primária (Real)
1 de junho de 2012
Conclusão do estudo (Real)
1 de junho de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
20 de outubro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de outubro de 2011
Primeira postagem (Estimativa)
24 de outubro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de março de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de março de 2017
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D208
- H-1-2010-124 (Outro identificador: The Regional Committee on Biomedical Research Ethics)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .