Completado

Polyunsaturates and KCL to Control Mild Hypertension

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

mineral supplements

+ Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements

+ dietary supplements

Suplemento DietéticoConductual
Quiénes están siendo reclutados

Enfermedades Cardiovasculares+1

+ Enfermedades del Corazón

+ Hipertensión

De 21 a 70 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con PlaceboFase 2
Intervencional
Inicio del estudio: diciembre de 1983
Ver detalles del protocolo

Resumen

Patrocinador PrincipalBrigham and Women's Hospital
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de diciembre de 1983

Fecha en la que se inscribió al primer participante.

BACKGROUND: The hypothesis that omega-3 fatty acids as well as magnesium and potassium in the diet lowered blood pressure in mild hypertensives needed further documentation, although preliminary and less well controlled studies had suggested such an effect was possible. In a previous study the investigators did not find a hypotensive effect of another polyunsaturated fatty acid, linoleic acid. In addition, findings of lower blood pressures in vegetarians and results obtained from a study in which vegetarian diets were fed to normotensives led to the conclusion that dietary factors other then linoleic acid were responsible for the possible hypotensive effect of vegetarian diets. The nutrients which were selected for further study, omega-3 fatty acids, magnesium and potassium, occur in higher amounts in vegetarian diets. Dietary supplementation with fish oils had only been done in a few studies with inconclusive results. However, the relationship of omega-3 fatty acids to the synthesis of prostacyclins, which are locally active vasodilators and which decrease with the excretion of the vasoconstrictor thromboxane, provide a possible mechanism for an effect of these compounds on blood pressure. The role of potassium in the control of blood pressure was first suggested from cross-cultural studies in which populations consuming high levels of potassium displayed lower rates of hypertension and a decrease in blood pressure with age. Cohort studies within this country have also shown a relationship between potassium intake or the ratio of potassium and sodium, as measured by urinary excretion and blood pressure. Most constantly it found that blood pressure differences between blacks and whites have been related to differences in potassium excretion. The results from human experimental studies involving potassium supplementation in normotensives and hypertensives have indicated mixed effects but blood pressure lowering was most consistently observed in subgroups with a family history of hypertension or those with higher blood pressure. DESIGN NARRATIVE: Trial 1: Subjects were randomized to a fish oil treatment group of 6 or 12 grams/day of omega-3 fatty acids or to a placebo group. At the end of 12 and 24 weeks, participants in the three groups were crossed-over to one of the other two treatments for an additional 12 weeks. The primary outcome was clinic blood pressure on 3 days at the end of the treatment period. Trial 2: Subjects were randomly assigned to one of four treatments and placebo: magnesium supplementation; potassium supplementation; calcium supplementation; all 3 supplements; matching placebos. The trial was double-blinded. Each of the treatments was administered for six months with measurements taken at baseline and at the end. The primary outcome was 24-hour ambulatory systolic BP. The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Título OficialPolyunsaturates and KCL to Control Mild Hypertension
NCT00000511
Patrocinador PrincipalBrigham and Women's Hospital
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 21 a 70 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

Enfermedades CardiovascularesEnfermedades del CorazónHipertensiónEnfermedades Vasculares

Criterios

Mild hypertensives, ages 21 to 70, with no evidence of end-organ damage.. Untreated hypertensives.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

100% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Placebo
Parallel study design, 4 treatment groups

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

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Este estudio no tiene datos de ubicaciónNo hay información disponible sobre las ubicaciones de este estudio.
CompletadoNingun centro de estudio