Vitamin D supplementation for prevention of placenta mediated pregnancy complications. - Prevention of pregnancy complications with vitamin D

• Conditions: MedDRA version: 12.1Level: LLTClassification code 10053759Term: Growth retardation; MedDRA version: 12.1Level: LLTClassification code 10036485Term: Pre-eclampsia; We will try to prevent preeclampsia, groth restriction and prematurity by vitamin D supplementation given as one dose in mid pregnancy; MedDRA version: 12.1Level: LLTClassification code 10036590Term: Premature baby

• Registration Number: EUCTR2010-019483-37-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-04
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

All pregnat women from 3 maternal health care units who accept to enter, alltogether 1000
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

<18 years of age
Hyperparathoroidism
Sarcoidosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Lower the incidence of placental related pregnancy complications (preeclampsia, growth restriction, and prematurity);Secondary Objective: Differences in blood flow in umbilical artery, blood loss at delivery, preeclampsia, growth restriction, or prematurity;Primary end point(s): See primary and secondary outcome