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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019483-37-SE
Enrollment
Unknown
Registered
2010-06-04
Start date
2011-04-06
Completion date
Unknown
Last updated
2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Vitamin D Forte Product Name: Cholekalciferol Product Code: A11CC01 Pharmaceutical Form: Oral drops* INN or Proposed INN: Cholekalciferol CAS Number: 50-14-6 Current Sponsor code: A11cc01

Sponsors

Karolinska University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: <18 years of age Hyperparathoroidism Sarcoidosis

Design outcomes

Primary

MeasureTime frame
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

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026