Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT01060735
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2010-01-31
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Study Start: 2010-11
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-22
• Primary Completion: 2012-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Larger doses of vitamin D supplementation	Vitamin D	The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Safety of vitamin D supplementation doses.	At the start of intervention, at delivery and at the age of one year

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petah Tikva, Israel