- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01910142
Effect of Nutrition on Bone Metabolism as Assessed by 41Ca
26 de julio de 2013 actualizado por: Henk FJ Hendriks, TNO
The Effect of Nutritional Intervention on Bone Metabolism as Assessed by 41Ca and Modeling; Proof of Concept
The present study aims to develop a technique based on a single dose of a calcium isotope, which enables to determine the effect of a nutritional intervention on bone calcium metabolism.
For this purpose nutritional interventions with calcium, vitamin D and vitamin K will be applied in postmenopausal women.
Treatment effects will be determined by the urinary excretion of the calcium isotope and related to classical bone markers.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In the present proposal a method is described that may enable studying the effect of nutrition on bone calcium turnover far more accurate, within a shorter time frame and therefore less intensive for the volunteers in clinical studies as compared to presently existing methods.
This method will enable screening for promising food concepts for combating osteoporosis within a relatively short time.
Recent developments show that use of the nuclide 41Calcium (41Ca) and measurement by accelerator mass spectrometry (AMS) has great potential in measuring effects on bone level within a relatively short period of time.
When introducing a diet change (intervention) the bone metabolism of calcium may change resulting in a changed 41Ca-signal in the urine.
So far a few medication studies with osteoporotic volunteers have been performed and it appears that this ultrahigh sensitive technique may also be applicable for nutrition studies in healthy volunteers.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años a 68 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
Healthy as assessed by the
- health and lifestyle questionnaire,
- physical examination
- results of the pre-study laboratory tests
- Females aged 50-68 years at Day 01 of the study
- Relatively low calcium intake as assessed by dairy intake questionnaire
- Body Mass Index (BMI) < 30 kg/m2
- Postmenopausal as confirmed by Follicle stimulating hormone (FSH) and oestradiol (E2) blood levels (FSH > 40IU/L, E2 < 70 pg/mL)
- Normal Dutch eating habits
- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Appropriate veins for blood sampling/cannula insertion according to TNO
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion Criteria:
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension and gastrointestinal disease
- Prescribed medication, including hormone replacement therapy (within 6 months before start of the study) and anticoagulant medication.
- Reported intolerance for dairy products
- Not willing to stop the use of Boerenkarnemelk and cheese of the following Dutch brands: Emmenthaler, Gruyere, Leer/Maasdammer
- Alcohol consumption > 21 units/week
- Not willing to stop use of supplements containing minerals or vitamins
- Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Reported vegan, vegetarian or macrobiotic
- Recent blood donation (<1 month prior to the start of the study)
- Not willing to give up blood donation during the study.
- Personnel of TNO Quality of Life, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from her general practitioner.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: calcium supplement with vitamin K
Milk product supplying about 420 mg Ca and 7.5 μg vitamin D3 and 100 μg vitamin K.
Additional 200 mg calcium in the form of carbonate
|
A calcium product will be given either with or without vitamin K.
Each intervention will last for 5 weeks, each followed by a 5 week wash-out.
The first intervention will start about 4 months after inclusion and the single 41Ca bolus.
|
|
Comparador de placebos: calcium supplement without vitamin K
Milk product supplying about 420 mg Ca and 7.5 μg vitamin D3. no vitamin K.
Additional 200 mg calcium in the form of carbonate
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
urinary 41calcium excretion
Periodo de tiempo: on study day numbers: 36, 71, 106, 113, 120, 127, 134, 141, 148, 155, 162, 169, 176, 183, 190, 197, 204, 211, 218, 225, 232, 239, 246, 253, 260, 267, 274, 281, 288
|
Urine is collected for measurement of 41Ca.
The concentration change of 41Ca during the intervention period indicates the efficacy of the intervention.
|
on study day numbers: 36, 71, 106, 113, 120, 127, 134, 141, 148, 155, 162, 169, 176, 183, 190, 197, 204, 211, 218, 225, 232, 239, 246, 253, 260, 267, 274, 281, 288
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
commonly accepted biomarkers for bone metabolism
Periodo de tiempo: on study day numbers: 148, 183, 218, 253, 288
|
Plasma osteocalcin and urinary deoxypyridinolin/creatinin ratio are measured as traditional markers for bone accretion and bone resorption respectively.
These are the most commonly used biomarkers for bone metabolism.
|
on study day numbers: 148, 183, 218, 253, 288
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Gertruud C Bakker, PhD, TNO
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2008
Finalización primaria (Actual)
1 de agosto de 2009
Finalización del estudio (Actual)
1 de agosto de 2009
Fechas de registro del estudio
Enviado por primera vez
9 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2013
Publicado por primera vez (Estimar)
29 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de julio de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
26 de julio de 2013
Última verificación
1 de julio de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Enfermedades musculoesqueléticas
- Enfermedades óseas
- Enfermedades Óseas Metabólicas
- Osteoporosis
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes moduladores de fibrina
- Micronutrientes
- Vitaminas
- Hormonas y agentes reguladores del calcio
- Agentes antifibrinolíticos
- Hemostáticos
- Coagulantes
- Vitamina K
- Calcio
Otros números de identificación del estudio
- 8145
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .