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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630603
First Posted: June 28, 2012
Last Update Posted: February 12, 2013
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.
Information provided by (Responsible Party):
Meir Medical Center
  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:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
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
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

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01630603     History of Changes
Other Study ID Numbers: MMC14-12
First Submitted: June 18, 2012
First Posted: June 28, 2012
Last Update Posted: February 12, 2013
Last Verified: June 2012

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