Vitamin D DeficiencyNCT01589783
Vitamin D During Pregnancy
An observational study of Vitamin D Deficiency, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of this vitamin for the proper development of the fetus, are a significant risk group. The purpose of this study is to examine which factors - education, knowledge from non-professional sources, recommendations from medical staff… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- completion of a questionnaire and Blood draw
- How many people
- 764 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Jun 2015
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We are recruiting either pregnant women or those who just gave birth (and still hospitalized) and a group of both family practice physicians and obstertricians.
Who may be able to join
None listed.
Who cannot join
- those who do not understand or read Hebrew
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Influence of Education, Knowledge and Existing Guidelines on the Consumption of Vitamin D During Pregnancy.
Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of this vitamin for the proper development of the fetus, are a significant risk group. The purpose of this study is to examine which factors - education, knowledge from non-professional sources, recommendations from medical staff - influence the use of vitamin D among pregnant women in light of the lack of a clear health policy, and to help formulating guidelines for a new health policy with specific recommendations for vitamin D dosage in pregnancy.
- Conditions
- Vitamin D Deficiency
- Being tested
- completion of a questionnaire, Blood draw
- Keywords
- Pregnancy, Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of a questionnaireOther
Completion of a questionnaire
Blood drawOther
A subset of 100 women will have a blood test to measure Vitamin D levels
| Study group | Role | What they receive |
|---|---|---|
| Pregnant or newly post partum women | Not described Receives: Other: completion of a questionnaire; Other: Blood draw | |
| family practice physicians and obstetricians | Not described Receives: Other: completion of a questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Vitamin D in Pregnant Women
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drorith Hochner, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589783
- Sponsor's protocol ID
- VitDand Preg-HMO-CTIL
- Status last verified
- Jul 2015
- First submitted
- 1 Apr 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Education, Knowledge and Existing Guidelines on the Consumption of Vitamin D During Pregnancy.
- ClinicalTrials.gov ID
- NCT01589783
- Acronym / sponsor ID
- VitDand Preg-HMO-CTIL
- Conditions
- Vitamin D Deficiency
- Keywords
- Pregnancy, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 May 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.
Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of this vitamin for the proper development of the fetus, are a significant risk group. The purpose of this study is to examine which factors - education, knowledge from non-professional sources, recommendations from medical staff - influence the use of vitamin D among pregnant women in light of the lack of a clear health policy, and to help formulating guidelines for a new health policy with specific recommendations for vitamin D dosage in pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant or newly post partum women | – | Other: completion of a questionnaire, Other: Blood draw |
| family practice physicians and obstetricians | – | Other: completion of a questionnaire |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We are recruiting either pregnant women or those who just gave birth (and still hospitalized) and a group of both family practice physicians and obstertricians.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- those who do not understand or read Hebrew
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion of a questionnaireCompletion of a questionnaire | Other | Pregnant or newly post partum women, family practice physicians and obstetricians |
| Blood drawA subset of 100 women will have a blood test to measure Vitamin D levels | Other | Pregnant or newly post partum women |
Primary outcome
Use of Vitamin D in Pregnant Women
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
Drorith Hochner, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Hadassah Medical Organization at 1 site 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 0 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: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Vitamin D in Pregnant Women (time frame: 3 months). 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 28 Jul 2015.