NCT02904720

Brief Summary

The purpose of this study is to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at the investigators' clinic. The further purposes are to identify the population at risk for vitamin D deficiency and to analyse whether vitamin D deficiency is associated with pregnancy complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,199

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 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

October 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

September 8, 2016

Last Update Submit

September 13, 2016

Conditions

Keywords

Vitamin D; Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Prevalence of vitamin D deficiency

    Number of patients with vitamin D deficiency after testing of vitamin D blood level at admission for prenatal care in our clinic

    Between the 1th and the 36th week of pregnancy

Secondary Outcomes (7)

  • BMI as a risk factor for vitamin D deficiency

    Between the 1th and the 36th week of pregnancy

  • Ethnicity as a risk factor for vitamin D deficiency

    Between the 1th and the 36th week of pregnancy

  • Age as risk factor for vitamin D deficiency

    Between the 1th and the 36th week of pregnancy

  • Period of the year as risk factor for vitamin D deficiency

    Between the 1th and the 36th week of pregnancy

  • Smoking Status as risk factor for vitamin D deficiency

    Between the 1th and the 36th week of pregnancy

  • +2 more secondary outcomes

Other Outcomes (3)

  • Association between vitamin D blood level and the mode of delivery at birth

    At delivery time

  • Association between vitamin D blood level and the gestational age at delivery

    At delivery time

  • Association between vitamin D blood level and newborn growth

    From week 1 until birth

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the pregnant women attending prenatal care and giving birth at birth at our clinic

You may qualify if:

  • Pregnant women attending prenatal care at our clinic who had a vitamin D blood-testing at admission

You may not qualify if:

  • Pregnant women lost to follow-up, Birth outside our clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Christoph P, Challande P, Raio L, Surbek D. High prevalence of severe vitamin D deficiency during the first trimester in pregnant women in Switzerland and its potential contributions to adverse outcomes in the pregnancy. Swiss Med Wkly. 2020 May 28;150:w20238. doi: 10.4414/smw.2020.20238. eCollection 2020 May 18.

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Daniel Surbek, Professor

    Insel Gruppe AG, University Hospital Bern

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 19, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 19, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations