NCT01630603

Brief Summary

Objectives:

  1. 1.To determine the incidence of vitamin D deficiency among Israeli pregnant women
  2. 2.To access whether maternal vitamin D status affects infant bone strength.
  3. 3.Vitamin D levels -in cord blood and maternal blood
  4. 4.The mother will fill a demographic and nutritional questionnaire
  5. 5.Growth assessment of the infants: weight length and head circumference
  6. 6.Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

February 12, 2013

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

June 18, 2012

Last Update Submit

February 11, 2013

Conditions

Maternal Vitamin D StatusNeonatal Bone Quantitative Ultrasound Measurements

Outcome Measures

Primary Outcomes (1)

  • Bone speed of sound and maternal vitamin D levels

    first tow days of life

Study Arms (1)

mother infants pairs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inborn mother infants pairs

You may qualify if:

  • mother-baby pairs,
  • birth week 35-42.
  • Jewish and Arab women that read and understand Hebrew.

You may not qualify if:

  • large neonatal congenital defects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Neonatal department Meir Medical Center

Kfar Saba, Israel

NOT YET RECRUITING

Central Study Contacts

Ita Litmanovich, MD

CONTACT

09-7471554litmani@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 28, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Last Updated

February 12, 2013

Record last verified: 2012-06

Locations

IL(3)