Maternal Vitamin D Status and Neonatal Bone Strength

Maternal Vitamin D Status Clinical Trial

— Vitamin D  

Official title:

Maternal Vitamin D Status and Neonatal Bone Strength

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01630603
• Other study ID #: MMC14-12
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2012
• Last updated: February 11, 2013
• Start date: July 2012

Study information

• Verified date: June 2012
• Source: Meir Medical Center
• Contact: Ita Litmanovich, MD
• Phone: 09-7471554
• Email: litmani[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Objectives:

1. To determine the incidence of vitamin D deficiency among Israeli pregnant women

2. To access whether maternal vitamin D status affects infant bone strength.

Methods:

1. Vitamin D levels -in cord blood and maternal blood

2. The mother will fill a demographic and nutritional questionnaire

The Infants:

3. Growth assessment of the infants: weight length and head circumference

4. Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• mother-baby pairs,

• birth week 35-42.

• Jewish and Arab women that read and understand Hebrew.

Exclusion Criteria:

• large neonatal congenital defects.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Maternal Vitamin D Status
• Neonatal Bone Quantitative Ultrasound Measurements

Locations

Country	Name	City	State
Israel	Neonatal department Meir Medical Center	Kfar Saba
Israel	Meir Medical Center	Kfar-Saba
Israel	Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone speed of sound and maternal vitamin D levels		first tow days of life	No