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Maternal Vitamin D Status and Neonatal Bone Strength

This study is currently recruiting participants.
Verified June 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01630603
First received: June 18, 2012
Last updated: February 11, 2013
Last verified: June 2012
History of Changes
  Purpose

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
Maternal Vitamin D Status
Neonatal Bone Quantitative Ultrasound Measurements

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Maternal Vitamin D Status and Neonatal Bone Strength

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Bone speed of sound and maternal vitamin D levels [ Time Frame: first tow days of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
mother infants pairs

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630603

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

Locations
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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01630603     History of Changes
Other Study ID Numbers: MMC14-12
Study First Received: June 18, 2012
Last Updated: February 11, 2013
Health Authority: Israel: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013