25- Hydroxyvitamin D Levels in Pregnancy and Effects on P... | NCT04637880

Studies
25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders

NCT04637880

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Nov 20, 2020Actual

Enrollment

249Actual

Phase

Not provided

Conditions

Vitamin d Deficiency
Preeclampsia
Preterm Delivery
Gestational Hypertension
Gestational Diabetes

Interventions

Not provided

Countries

Austria

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 1, 2018Actual

First Submitted Date

Jun 21, 2014

First Submission Date that Met QC Criteria

Nov 16, 2020

First Posted Date

Nov 20, 2020Actual

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

Nov 16, 2020

Last Update Posted Date

Nov 20, 2020Actual

Name	Class
Ratiopharm GmbH	INDUSTRY

Description Module

Brief 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

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

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

249Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
25- Hydroxyvitamin D and relation to development of preeclampsia		over course of pregnancy

Secondary Outcomes

Measure	Description	Time Frame
25 Hydroxyvitamin D in newborn		once at delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

healthy pregnant women

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harald Zeisler, Univ. Prof. Dr.	MUV	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and fetomaternal Medicine, Medical University of Vienna		Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency
D011225	Pre-Eclampsia
D047928	Premature Birth
D046110	Hypertension, Pregnancy-Induced
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided