WCCR-ARTH2A Nutrition Intervention for Arthritis-2
Plant-based diet
+ Supplement
Artritis+5
+ Enfermedades Autoinmunes
+ Enfermedades del Tejido Conectivo
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de octubre de 2012
Fecha en la que se inscribió al primer participante.Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. The investigators will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measure is pain as measured by Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and tender joints, respectively. The Beck Depression Inventory II (BDI-II)will be used to measure changes in mood. The study duration is 36 weeks.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 6 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 90 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: A diagnosis of rheumatoid arthritis based on 2010 ACR / EULAR Rheumatoid Arthritis Classification Criteria. Classification as "definite RA" is based on: the confirmed presence of synovitis in at least 1 joint absence of an alternative diagnosis that better explains the synovitis and achievement of a total score of 6 or greater (of a possible 10): 24 Joint involvement, designating the metacarpophalangeal joints, proximal interphalangeal joints, the interphalangeal joint of the thumb, second through third metatarsophalangeal joint and wrist as small joints, and elbows, hip joints and knees as large joints: Involvement of 1 large joint gives 0 points Involvement of 2-10 large joints gives 1 point Involvement of 1-3 small joints (with or without involvement of large joints) gives 2 points Involvement of 4-10 small joints (with or without involvement of large joints) gives 3 points Involvement of more than 10 joints (with involvement of at least 1 small joint) gives 5 points Serological parameters - including the rheumatoid factor as well as anti-citrullinated protein antibody (ACPA): Negative RF and negative ACPA gives 0 points Low-positive RF or low-positive ACPA gives 2 points High-positive RF or high-positive ACPA gives 3 points Acute phase reactants: 1 point for elevated erythrocyte sedimentation rate (ESR) or elevated C-reactive protein (CRP) value Duration of arthritis: 1 point for symptoms lasting six weeks or longer Continuing or recurring pain (i.e., joint pain daily, unless on pain medication). Age at least 18 years Ability and willingness to participate in all components of the study Willingness to be assigned to either the diet group or supplement group Pain medications unchanged within last 6 weeks. Exclusion Criteria: < 18 years of age Rheumatoid arthritis for more than 6 years Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion) Pregnancy Unstable medical or psychiatric illness Likely to be disruptive in group sessions (as determined by research staff) Already following a low-fat, vegan diet Lack of English fluency Inability to maintain current medication regimen Inability or unwillingness to participate in all components of the study
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Physicians Committee for Responsible Medicine
Washington D.C., United StatesAbrir Physicians Committee for Responsible Medicine en Google Maps