Clinical trial NCT01060735: Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Vitamin D
pregnancy
children
bone
quantitative ultrasound
Healthy pregnant women
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).
timeFrame: Bone status in offsprings, assessed at the age of one year
Secondary outcomes:
measure: Vitamin D status of mothers.
timeFrame: At the start of intervention, at delivery and at the age of one year
measure: Maternal health status.
timeFrame: At the start of intervention, at delivery and at the age of one year
measure: Infants' growth.
timeFrame: At the start of intervention, at delivery and at the age of one year
measure: Vitamin D status in infants.
timeFrame: At the start of intervention, at delivery and at the age of one year
measure: Safety of vitamin D supplementation doses.
timeFrame: At the start of intervention, at delivery and at the age of one year
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Rabin Medical Center
name: Corina Hartman, MD
role: PRINCIPAL_INVESTIGATOR
References: