- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630603
Maternal Vitamin D Status and Neonatal Bone Strength (Vitamin D)
February 11, 2013 updated by: Meir Medical Center
Objectives:
- To determine the incidence of vitamin D deficiency among Israeli pregnant women
- To access whether maternal vitamin D status affects infant bone strength.
Methods:
- Vitamin D levels -in cord blood and maternal blood
The mother will fill a demographic and nutritional questionnaire
The Infants:
- Growth assessment of the infants: weight length and head circumference
- Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kfar Saba, Israel
- Not yet recruiting
- Neonatal department Meir Medical Center
-
Contact:
- Ita Litmanovich, MD
-
Principal Investigator:
- Ita Litmanovich, MD
-
Kfar-Saba, Israel
- Recruiting
- Meir Medical Center
-
Contact:
- Ita Litmanovits
- Phone Number: 09-7471154
- Email: litmani@clalit.org.il
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Principal Investigator:
- Ita Litmanovitz, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Inborn mother infants pairs
Description
Inclusion Criteria:
- mother-baby pairs,
- birth week 35-42.
- Jewish and Arab women that read and understand Hebrew.
Exclusion Criteria:
- large neonatal congenital defects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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mother infants pairs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bone speed of sound and maternal vitamin D levels
Time Frame: first tow days of life
|
first tow days of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
June 18, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 28, 2012
Study Record Updates
Last Update Posted (Estimate)
February 12, 2013
Last Update Submitted That Met QC Criteria
February 11, 2013
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- MMC14-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Maternal Vitamin D Status
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Tirang R. Neyestani, Ph.D.National Nutrition and Food Technology InstituteCompletedMaternal Vitamin D StatusIran, Islamic Republic of
-
University of UlsterNorthern Ireland Executive; HSC Public Health AgencyCompletedVitamin D Status | Vitamin D ConcentrationUnited Kingdom
-
University of CopenhagenCompleted
-
Sheffield Children's NHS Foundation TrustCompleted
-
Bispebjerg HospitalThe Danish Medical Research CouncilCompleted
-
Bispebjerg HospitalVejle HospitalCompletedVitamin D StatusDenmark
-
University of TorontoCompleted
-
Creighton UniversityThe UV FoundationCompleted
-
Creighton UniversityCompletedVitamin D StatusUnited States
-
National Nutrition and Food Technology InstituteCompletedHealthy | Vitamin D Status