Vitamin d DeficiencyVIDISNCT04637880
25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders
An observational study of Vitamin d Deficiency and Preeclampsia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Evaluation of 25- Hydroxyvitamin D levels in pregnant women in Austria and potential related disorders Hypothesis: Austrian pregnant women are Vitamin D deficient Present vitamin D supplementation in pregnancy is insufficient Vitamin D deficiency is associated with pregnancy related disorders like preeclampsia Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin d Deficiency, Preeclampsia, Preterm Delivery
- How many people
- 249 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2012to 1 Jul 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy pregnant women
Who may be able to join
- age> 18 years
- informed consent
Who cannot join
- chronic hypertension
- kidney disease
- lupus erythematodes
- diabetes mellitus
- malabsorption syndrome
- hyperparathyroidism
- surgery on the thyroid gland
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Obstetrics and fetomaternal Medicine, Medical University of Vienna
Vienna, 1090
About this study
Evaluation of 25- Hydroxyvitamin D levels in pregnant women in Austria and potential related disorders
Hypothesis:
Austrian pregnant women are Vitamin D deficient Present vitamin D supplementation in pregnancy is insufficient Vitamin D deficiency is associated with pregnancy related disorders like preeclampsia
- Conditions
- Vitamin d Deficiency, Preeclampsia, Preterm Delivery, Gestational Hypertension, Gestational Diabetes
- Medical subject headings
- Vitamin D Deficiency, Pre-Eclampsia, Premature Birth, Hypertension, Pregnancy-Induced, Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
25- Hydroxyvitamin D and relation to development of preeclampsia
Measured: over course of pregnancy
Secondary outcomes (1)
25 Hydroxyvitamin D in newborn
Measured: once at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study startJul 2012
- Primary completionJul 2018
- Study completion1 Jul 2018
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Ratiopharm GmbH
- Responsible party
- Principal investigator, Julia Wild, MD, Medical University of Vienna
- Investigators
- Harald Zeisler, Univ. Prof. Dr., Principal investigator, MUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637880
- Sponsor's protocol ID
- V02
- Acronym
- VIDIS
- Status last verified
- Nov 2020
- First submitted
- 21 Jun 2014
- Last updated
- 20 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders
- ClinicalTrials.gov ID
- NCT04637880
- Acronym / sponsor ID
- VIDIS / V02
- Conditions
- Vitamin d Deficiency, Preeclampsia, Preterm Delivery, Gestational Hypertension, Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Ratiopharm GmbH
- Study start
- Jul 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 20 Nov 2020 (actual)
- 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.
Evaluation of 25- Hydroxyvitamin D levels in pregnant women in Austria and potential related disorders
Hypothesis:
Austrian pregnant women are Vitamin D deficient Present vitamin D supplementation in pregnancy is insufficient Vitamin D deficiency is associated with pregnancy related disorders like preeclampsia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy pregnant women
Key inclusion criteria (2 listed)
- age> 18 years
- informed consent
Key exclusion criteria (7 listed)
- chronic hypertension
- kidney disease
- lupus erythematodes
- diabetes mellitus
- malabsorption syndrome
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
25- Hydroxyvitamin D and relation to development of preeclampsia
Time frame: over course of pregnancy
1 secondary outcome
25 Hydroxyvitamin D in newborn
Time frame: once at delivery
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 20 Nov 2020.
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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.
Harald Zeisler, Univ. Prof. Dr. principal investigator
MUV
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 and Preeclampsia, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 7 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 20 Nov 2020. 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 Austria. 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?
25- Hydroxyvitamin D and relation to development of preeclampsia (time frame: over course of pregnancy). 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 20 Nov 2020.