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Selenium in pregnancy intervention

Selenium in PRegnancy INTervention: a double-blind, randomised, placebo-controlled, two-group study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37927591
Enrollment
230
Registered
2013-05-10
Start date
2009-02-16
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia, unspecified

Interventions

Two treatment groups: 60 mcg/day of selenium as selenium-enriched yeast or placebo yeast (60 mcg/day is the recommended intake for UK pregnant women). Total duration of intervention: From randomisati

Sponsors

University of Surrey (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. First pregnancy 2. 12-14 weeks pregnant at randomisation

Exclusion criteria

Exclusion criteria: 1. Under 18 years old 2. Current smokers (who have lower risk of pre-eclampsia) 3. Taking any supplement containing Se 4. Taking thyroid medication 5. Multiple pregnancy 6. Abnormal fetal anomaly scan 7. Chronic proteinuria 8. Heparin treatment 9. Human immunodeficiency virus (HIV), Hep-B or Hep-C positive 10. Yeast intolerance (supplement contains yeast)# 11. inability or refusal to give informed consent (the genetic component of the trial will be omitted in those who do not give explicit consent to this aspect of the trial)

Design outcomes

Primary

MeasureTime frame
Plasma soluble fms-like tyrosine kinase-1 (sFlt-1) concentration. Measured in samples taken at 35 weeks gestation.

Secondary

MeasureTime frame
Plasma concentrations of: placental growth factor (PlGF), sEndoglin, ActivinA, InhibinA, E-selectin, vascular cell adhesion molecule 1 (VCAM-1), 3-Nitrotyrosine, Pentraxin 3, C-reactive protein (CRP). Measured in samples taken at 35 weeks gestation.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026