ECE2017 Oral Communications Thyroid Disease 2 (5 abstracts)
Selenium supplementation in the management of thyroid autoimmunity during pregnancy: results of the ‘Serena Study’ a randomized, double-blind, placebo-controlled trial
Carla Di Dato 1 , Giovanna Mantovani 2 , Costanzo Moretti 3 , Ermanno Greco 4 , Marco Bonomi 5 , Antongiulio Faggiano 6 , Stefania Di Sante 1 , Vincenzo Giannetta 1 , Luisa Petrone 7 , Angela Fumarola 1 , Annamaria Colao 8 , Andrea Lenzi 1 , Andrea M. Isidori 1 & Elisa Giannetta 1
1Department of Experimental Medicine - Sapienza University of Rome, Rome, Italy; 2Endocrine Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy; 3Unit of Endocrinology, Section of Reproductive Endocrinology, Department of Systems’ Medicine, University of Rome Tor Vergata, Rome, Italy; 4Centre for Reproductive Medicine, European Hospital, Rome, Italy; 5Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy; 6Thyroid and Parathyroid Surgery Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori-IRCCS, Fondazione G. Pascale”, Naples, Italy; 7Endocrinology Unit, Careggi Hospital and University of Florence, Florence, Italy; 8Endocrinology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Autoimmune thyroiditis and related complications represent a growing concern during pregnancy. Selenium is frequently present in nutraceuticals recommended for thyroiditis and pregnancy, given its advocated role in immunity, fertility and thyroid function. However, most evidences come from non-controlled studies. Materials and Methods
We designed a multicenter, randomized, double-blind, placebo-controlled trial (Serena Study: NCT01465867) to evaluate the effects of L-selenomethionine (Se) supplementation on antibodies title in euthyroid women with positive anti-thyroid antibodies that are pregnant or undergoing in-vitro fertilization. Secondary outcomes included: implantation rates, pregnancy rate, delivery, obstetrical, fetal and neonatal complications. Ten endocrinology and gynecology Italian referral centers participated. The study was promoted and supported by EnGioI Club (Italian Young Endocrinology).
Results
56 women were randomly assigned to placebo (PLB) or Se 83 mcg/die. Thyroid hormones, TgAb, TPOAb, selenium concentration were measured during pregnancy and after labor (months 3° to 6°). All analysis were centralized. Of the enrolled women, 45 (80.3%) were pregnant and 11 (19.6%) embryo transferred. A significant reduction of TgAb was observed in Se-treated women after labor: treatment effect d=108.67 (95%CI:−1.3, 218.6; P=0.03). The change in antibodies was paralleled by a significant increase in selenium serum concentration measured already at 36±2 weeks: (PLB:−11±23.76, Se:+30.5±17.63; treatment effect d=35.57 95% CI:14.9, 62.3; P=0.004) and confirmed after labor: treatment effect d=17.56 (95% CI: 3.9, 31.2; P=0.014). Post-labor rebound in antibodies’ title of PLB treated, as compared to Se-treated women was paralleled by a trend toward TSH rise (PLB:+3.96±12.56 vs Se: +1.69±6.00). Safety analysis showed no discontinuation in the Se-treated subjects. Two miscarriage occurred in PLB vs 0 in Se-treated. No differences were found in fetal and maternal complications. The pregnancy rate after embryo transfer was 3/5 (60%) in Se-treated vs 1/6 (16.6%) in PLB.
Conclusion
SERENA Study demonstrated a beneficial effect on the title of TgAb with a safety profile. Larger studies are needed to confirm the trends observed on post-partum thyroiditis recurrence and hypothyroidism, miscarriage and pregnancy rate in in vitro-fertilization.
Volume 49
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