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

NCT01060735 | Unknown

• 1 other identifier: rmc005437ctil
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Vitamin D; pregnancy; children; bone; quantitative ultrasound; Healthy pregnant women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Larger doses of vitamin D supplementation

EXPERIMENTAL

The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day

Dietary Supplement: Vitamin D

Conventional vitamin D supplementation

NO INTERVENTION

Regular supplementation during pregnancy with 400IU vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Larger doses of vitamin D supplementation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women aged 20 to 40 years, of any parity status.
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

RECRUITING

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Corina Hartman, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corina Hartman, MD

CONTACT

972-3-9253674; corinah@clalit.org.il

Raanan Shamir, Professor

CONTACT

972-3-9253673; raanans@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2010
• First Posted: February 2, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

IL (1)