Maternal Vitamin D StatusVitamin DNCT01630603
Maternal Vitamin D Status and Neonatal Bone Strength
An observational study of Maternal Vitamin D Status and Neonatal Bone Quantitative Ultrasound Measurements, run by Meir Medical Center at 3 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maternal Vitamin D Status, Neonatal Bone Quantitative Ultrasound Measurements
- How many people
- 100 participants
- Where
- 3 sitesIsrael
- Study dates
- Jul 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inborn mother infants pairs
Who may be able to join
- mother-baby pairs,
- birth week 35-42.
- Jewish and Arab women that read and understand Hebrew.
Who cannot join
- large neonatal congenital defects.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Ita Litmanovitz Litmanovitz, MD
- Recruiting
Meir Medical Center
Kfar Saba
Ita Litmanovits, 09-7471154, litmani@clalit.org.il
Ita Litmanovitz, MD
- Not yet recruiting
Neonatal department Meir Medical Center
Kfar Saba
Ita Litmanovich, MD
Ita Litmanovich, MD
About this study
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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mother infants pairs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone speed of sound and maternal vitamin D levels
Measured: first tow days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Vitamin D StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630603
- Sponsor's protocol ID
- MMC14-12
- Acronym
- Vitamin D
- Status last verified
- Jun 2012
- First submitted
- 18 Jun 2012
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Vitamin D Status and Neonatal Bone Strength
- ClinicalTrials.gov ID
- NCT01630603
- Acronym / sponsor ID
- Vitamin D / MMC14-12
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mother infants pairs | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inborn mother infants pairs
Key inclusion criteria (3 listed)
- mother-baby pairs,
- birth week 35-42.
- Jewish and Arab women that read and understand Hebrew.
Key exclusion criteria (1 listed)
- large neonatal congenital defects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone speed of sound and maternal vitamin D levels
Time frame: first tow days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Vitamin D Status and Neonatal Bone Quantitative Ultrasound Measurements, run by Meir Medical Center at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ita Litmanovich, MD (09-7471554, litmani@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone speed of sound and maternal vitamin D levels (time frame: first tow days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.