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Search / Trial NCT01465867

Selenium Supplementation in Pregnancy

Launched by UNIVERSITY OF ROMA LA SAPIENZA · Nov 4, 2011

Trial Information

Current as of May 16, 2025

Completed

Keywords

Selenium Pregnancy Auto Immune Thyroiditis Post Partum Thyroiditis Miscarriage Pre Eclampsia Implantation And Pregnancy Rate Infertility

ClinConnect Summary

Adverse outcomes, postpartum thyroid dysfunction and permanent hypothyroidism have been associated with isolated TPOab positivity in euthyroid pregnant women.

In areas with severe selenium deficiency there is a higher incidence of thyroiditis due to a decreased activity of selenium-dependent glutathione peroxidase activity within thyroid cells. Selenium-dependent enzymes also have several modifying effects on the immune system. Therefore, even mild selenium deficiency may contribute to the development and maintenance of autoimmune thyroid diseases.

Selenium substitution exerts anti-inflam...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • pregnant women with 10°± 2 weeks of gestation
  • women in whom embryo transfer is expected within 60 days
  • euthyroid women (0.4 μIU/ml \< TSH \< 2.5 μIU/ml), positive for TPOab and/or TgAb, not assuming LT4 replacement
  • euthyroid women (0.4 μIU/ml \< TSH \< 2.5 μIU/ml), positive for TPOab and/or TgAb under LT4 replacement (to maintain TSH within the control range).
  • women with TSH \> 2.5 μIU/ml positive for TPOab and/or TgAb, not assuming LT4 replacement (requiring the beginning of LT4 replacement)
  • women with TSH \> 2.5 μIU/ml positive for TPOab and/or TgAb, under LT4 replacement (requiring an adjustment of LT4 replacement)
  • Exclusion Criteria:
  • use of dietary supplements containing selenium in the previous 4 months;
  • use of antidepressive/psychotic drugs, amiodarone, propanolol, lithium, cytokines;
  • history of hyperthyroidism positive anti-thyrotropin ab;
  • previous partial or total thyroidectomy;
  • known fetal anomaly;
  • known infections (PID, HIV, HCV) and mola hydatidoses;
  • chronic renal failure;
  • uncontrolled hypertension;
  • uterine malformation;
  • history of medical and metabolic complication such as heart disease or diabetes;
  • previous embryo transfer failed within last 3 months;
  • miscarriage within last 3 months;
  • gestational diabetes in previous pregnancies.

About University Of Roma La Sapienza

The University of Roma La Sapienza, one of Italy's premier research institutions, is dedicated to advancing medical science and improving patient outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses its extensive expertise in diverse fields, including medicine, biotechnology, and public health, to conduct rigorous and ethically sound research. Committed to fostering educational excellence and promoting groundbreaking discoveries, La Sapienza actively engages in clinical trials that aim to address critical health challenges and contribute to the development of new therapeutic interventions.

Locations

Milan, , Italy

Naples, , Italy

Florence, , Italy

Milan, , Italy

Novara, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

Andrea M Isidori, MD, PhD

Principal Investigator

Department of Experimental Medicine, Section of Clinical Pathophysiology and Endocrinology, "Sapienza" University of Rome

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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