Maternal Vitamin D Status and Neonatal Bone Strength | NCT01630603

Studies
Maternal Vitamin D Status and Neonatal Bone Strength

NCT01630603

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Feb 12, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Maternal Vitamin D Status
Neonatal Bone Quantitative Ultrasound Measurements

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2014Estimated

Completion Date

Not provided

First Submitted Date

Jun 18, 2012

First Submission Date that Met QC Criteria

Jun 27, 2012

First Posted Date

Jun 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2013

Last Update Posted Date

Feb 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
mother infants pairs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone speed of sound and maternal vitamin D levels		first tow days of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Inborn mother infants pairs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ita Litmanovich, MD	Contact	09-7471554		litmani@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center	Recruiting	Kfar Saba			Israel