Healthy
Conditions
Keywords
Vitamin D, pregnancy, children, bone, quantitative ultrasound, Healthy pregnant women
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS). | Bone status in offsprings, assessed at the age of one year |
Secondary
| Measure | Time frame |
|---|---|
| Safety of vitamin D supplementation doses. | At the start of intervention, at delivery and at the age of one year |
| Vitamin D status of mothers. | At the start of intervention, at delivery and at the age of one year |
| Maternal health status. | At the start of intervention, at delivery and at the age of one year |
| Infants' growth. | At the start of intervention, at delivery and at the age of one year |
| Vitamin D status in infants. | At the start of intervention, at delivery and at the age of one year |
Countries
Israel
Contacts
Primary ContactCorina Hartman, MD
Backup ContactRaanan Shamir, Professor
Outcome results
None listed