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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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)

Condition or disease
Maternal Vitamin D Status Neonatal Bone Quantitative Ultrasound Measurements

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Maternal Vitamin D Status and Neonatal Bone Strength
Study Start Date : July 2012
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Groups and Cohorts
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Group/Cohort
mother infants pairs


Outcome Measures
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Primary Outcome Measures :
  1. Bone speed of sound and maternal vitamin D levels [ Time Frame: first tow days of life ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inborn mother infants pairs
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630603


Contacts
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Contact: Ita Litmanovich, MD 09-7471554 litmani@clalit.org.il

Locations
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Israel
Neonatal department Meir Medical Center Not yet recruiting
Kfar Saba, Israel
Contact: Ita Litmanovich, MD         
Principal Investigator: Ita Litmanovich, MD         
Meir Medical Center Recruiting
Kfar-Saba, Israel
Contact: Ita Litmanovitz Litmanovitz, MD         
Meir Medical Center Recruiting
Kfar-Saba, Israel
Contact: Ita Litmanovits    09-7471154    litmani@clalit.org.il   
Principal Investigator: Ita Litmanovitz, MD         
Sponsors and Collaborators
Meir Medical Center
More Information
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01630603    
Other Study ID Numbers: MMC14-12
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: June 2012