NCT02434900

Brief Summary

The Vitamin D and Angiogenic Marker Study 1: Vitamin D and angiogenic markers in early pregnancy. Epidemiology and associations to early-pregnancy miscarriage

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,874

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress75%
Jan 2010Dec 2031

Study Start

First participant enrolled

January 1, 2010

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

21.9 years

First QC Date

November 20, 2014

Last Update Submit

May 5, 2015

Conditions

Abortion, Spontaneous

Outcome Measures

Primary Outcomes (1)

  • Spontaneous Abortion

    Occurrence of spontaneous abortion, as diagnosed by transvaginal ultrasound in medical files. The time from inclusion in cohort to occurrance of spontaneous abortion was on average 13 days.

    Outcome is assessed in gestational weeks 5+0 to 22+0.

Eligibility Criteria

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

The Odense Child Cohort Study (OCC) is a population-based cohort study, comprising pregnant women recruited between January 1st 2010 and December 31st 2012. All women who were pregnant in the municipality of Odense during this time were eligible for participation, and 6,707 women were approached directly with recruitment material. The study complied with the Helsinki declaration and was approved by the Regional Scientific Ethical Committee for Southern Denmark, no. S-20090130. All participants gave informed consent. From a population base of 6,70 pregnant women, 2,874 (42.9%) enrolled in the OCC up to December 31st, 2012. The children will be followed until 18 years of age.

You may qualify if:

  • Pregnant and residing in the municipality of Odense during 2010-2012

You may not qualify if:

  • Not residing in Odense, leaving the municipality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCA Research, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (6)

  • Galthen-Sorensen M, Andersen LB, Sperling L, Christesen HT. Maternal 25-hydroxyvitamin D level and fetal bone growth assessed by ultrasound: a systematic review. Ultrasound Obstet Gynecol. 2014 Dec;44(6):633-40. doi: 10.1002/uog.13431.

    PMID: 24891235BACKGROUND

  • Christesen HT, Elvander C, Lamont RF, Jorgensen JS. The impact of vitamin D in pregnancy on extraskeletal health in children: a systematic review. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1368-80. doi: 10.1111/aogs.12006.

    PMID: 23210535BACKGROUND

  • Christesen HT, Falkenberg T, Lamont RF, Jorgensen JS. The impact of vitamin D on pregnancy: a systematic review. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1357-67. doi: 10.1111/aogs.12000. Epub 2012 Oct 17.

    PMID: 22974137BACKGROUND

  • Christesen HT, Andersen LB. Reply to: 'vitamin D deficiency during pregnancy: confronting the issues'. Clin Endocrinol (Oxf). 2014 Jul;81(1):155-6. doi: 10.1111/cen.12328. Epub 2013 Oct 15. No abstract available.

    PMID: 24102268RESULT

  • Andersen LB, Abrahamsen B, Dalgard C, Kyhl HB, Beck-Nielsen SS, Frost-Nielsen M, Jorgensen JS, Barington T, Christesen HT. Parity and tanned white skin as novel predictors of vitamin D status in early pregnancy: a population-based cohort study. Clin Endocrinol (Oxf). 2013 Sep;79(3):333-41. doi: 10.1111/cen.12147. Epub 2013 Jul 2.

    PMID: 23305099RESULT

  • Andersen LB, Jorgensen JS, Jensen TK, Dalgard C, Barington T, Nielsen J, Beck-Nielsen SS, Husby S, Abrahamsen B, Lamont RF, Christesen HT. Vitamin D insufficiency is associated with increased risk of first-trimester miscarriage in the Odense Child Cohort. Am J Clin Nutr. 2015 Sep;102(3):633-8. doi: 10.3945/ajcn.114.103655. Epub 2015 Jul 15.

    PMID: 26178723DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Henrik T Christesen, MD, PhD

    Project leader

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor

Study Record Dates

First Submitted

November 20, 2014

First Posted

May 6, 2015

Study Start

January 1, 2010

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

May 6, 2015

Record last verified: 2015-04

Locations

DK(1)