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

NCT ID: NCT01060735

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery

Conventional vitamin D supplementation

Regular supplementation during pregnancy with 400IU vitamin D

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D

Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rabin Medical Center

Principal Investigators

Corina Hartman, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Corina Hartman, MD

Role: CONTACT

corinah@clalit.org.il

972-3-9253674

Raanan Shamir, Professor

Role: CONTACT

raanans@clalit.org.il

972-3-9253673

Other Identifiers

rmc005437ctil

Identifier Type: -

Identifier Source: org_study_id