Maternal Vitamin D Status and Neonatal Bone Strength

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Meir Medical Center.
Recruitment status was  Recruiting
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
  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 ] [ 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
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, see Learn About Clinical Studies.

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 July 22, 2014