- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04637880
25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders (VIDIS)
November 16, 2020 updated by: Julia Wild, MD, Medical University of Vienna
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 Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
249
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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Vienna, Austria, 1090
- Department of Obstetrics and fetomaternal Medicine, Medical University of Vienna
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
healthy pregnant women
Description
Inclusion Criteria:
- age> 18 years
- informed consent
Exclusion Criteria:
- chronic hypertension
- kidney disease
- lupus erythematodes
- diabetes mellitus
- malabsorption syndrome
- hyperparathyroidism
- surgery on the thyroid gland
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
25- Hydroxyvitamin D and relation to development of preeclampsia
Time Frame: over course of pregnancy
|
over course of pregnancy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
25 Hydroxyvitamin D in newborn
Time Frame: once at delivery
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once at delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Harald Zeisler, Univ. Prof. Dr., MUV
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 (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
June 21, 2014
First Submitted That Met QC Criteria
November 16, 2020
First Posted (Actual)
November 20, 2020
Study Record Updates
Last Update Posted (Actual)
November 20, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Hypertension
- Vitamin D Deficiency
- Premature Birth
- Pre-Eclampsia
- Diabetes, Gestational
- Hypertension, Pregnancy-Induced
Other Study ID Numbers
- V02
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.
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