NCT04637880

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

6 years

First QC Date

June 21, 2014

Last Update Submit

November 16, 2020

Conditions

Vitamin d DeficiencyPreeclampsiaPreterm DeliveryGestational HypertensionGestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • 25- Hydroxyvitamin D and relation to development of preeclampsia

    over course of pregnancy

Secondary Outcomes (1)

  • 25 Hydroxyvitamin D in newborn

    once at delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy pregnant women

You may qualify if:

  • age\> 18 years
  • informed consent

You may not qualify if:

  • chronic hypertension
  • kidney disease
  • lupus erythematodes
  • diabetes mellitus
  • malabsorption syndrome
  • hyperparathyroidism
  • surgery on the thyroid gland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and fetomaternal Medicine, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Vitamin D DeficiencyPre-EclampsiaPremature BirthHypertension, Pregnancy-InducedDiabetes, Gestational

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsHypertensionVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Harald Zeisler, Univ. Prof. Dr.

    MUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ

Study Record Dates

First Submitted

June 21, 2014

First Posted

November 20, 2020

Study Start

July 1, 2012

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

AU(1)