Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age
The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age
Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.
We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.
The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.
Descripción general del estudio
Descripción detallada
This is a prospective randomized controlled study.
120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.
25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.
25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.
Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.
Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.
Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Petah Tikva, Israel, 49202
- Reclutamiento
- Schneider Children's Medical Center of Israel
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Sub-Investigador:
- Raanan Shamir, Professor
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Sub-Investigador:
- Eran Adar, MD
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Sub-Investigador:
- Moshe Hod, Professor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy pregnant women aged 20 to 40 years, of any parity status.
- Signed informed consent
Exclusion Criteria:
- Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders
- Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Larger doses of vitamin D supplementation
The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day
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Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery
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Sin intervención: Conventional vitamin D supplementation
Regular supplementation during pregnancy with 400IU vitamin D
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).
Periodo de tiempo: Bone status in offsprings, assessed at the age of one year
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Bone status in offsprings, assessed at the age of one year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Vitamin D status of mothers.
Periodo de tiempo: At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Maternal health status.
Periodo de tiempo: At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Infants' growth.
Periodo de tiempo: At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Vitamin D status in infants.
Periodo de tiempo: At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Safety of vitamin D supplementation doses.
Periodo de tiempo: At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Corina Hartman, MD, Rabin Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- rmc005437ctil
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