Selenium Supplementation in Pregnancy
Launched by UNIVERSITY OF ROMA LA SAPIENZA · Nov 4, 2011
Trial Information
Current as of May 16, 2025
Completed
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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