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Maternal Vitamin D Status and Neonatal Bone Strength (Vitamin D)

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ClinicalTrials.gov Identifier: NCT01630603
Recruitment Status : Unknown
Verified June 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date June 18, 2012
First Posted Date June 28, 2012
Last Update Posted Date February 12, 2013
Study Start Date July 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2013)
Bone speed of sound and maternal vitamin D levels [ Time Frame: first tow days of life ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal Vitamin D Status and Neonatal Bone Strength
Official Title Maternal Vitamin D Status and Neonatal Bone Strength
Brief 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)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inborn mother infants pairs
Condition
  • Maternal Vitamin D Status
  • Neonatal Bone Quantitative Ultrasound Measurements
Intervention Not Provided
Study Groups/Cohorts mother infants pairs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 27, 2012)
100
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • large neonatal congenital defects.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01630603
Other Study ID Numbers MMC14-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date June 2012