A group randomized to receive organic selenium in the form of L-selenomethionine at the dose of 200mcg daily (intervention group) for 6 months

A group randomized to receive placebo (control group) for 6 months

Autoimmune Thyroiditis

The group will be randomized to receive organic selenium in the form of L-selenomethionine at the dose of 200mcg daily (intervention group) for 6 months

L-selenomethionine

The group will be randomized to receive placebo (control group) for 6 months

Placebo

Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki

Selenium Supplementation in Youths With Autoimmune Thyroiditis

L-selenomethionine Supplementation in Children and Adolescents With Autoimmune Thyroiditis: a Randomized Blind Placebo-controlled Clinical Trial

Hypothyroid state will be defined as the state of abnormal thyroid function that requires substitution treatment with L-thyroxine; in particular, if thyroid-stimulating hormone (TSH) serum levels are greater than 5 micro-units per milliliter (mcU/ml) and/or the levels of fT4 or fT3 are decreased. Otherwise the state will be considered as euthyroid.

Assimina Galli-Tsinopoulou

ASSSOCIATE PROFESSOR

Aristotle University Of Thessaloniki

Pregnancy

Infertility

Auto-immune Thyroiditis

83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour

Selenium

Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour.

Sugar Pill Placebo

83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour
+ LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)

Selenium + L-Thyroxine (LT4)

Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour
+ LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)

Sugar Pill Placebo + L-Thyroxine (LT4)

Azienda ospedaliero-universitaria Careggi

Istituto Auxologico Italiano

Ospedale Maggiore Policlinico

University Federico II

University "Piemonte Orientale, A. Avogadro"

Torvergata University of Rome - Ospedale S. Eugenio

European Hospital

Ospedale S. Giovanni Calibita Fatebenefratelli

Department of Experimental Medicine, "Sapienza" University of Rome

Department of Gynecological/Obstetric/Urological Sciences, "Sapienza" University of Rome

Dpt of Experimental Medicine

Selenium Supplementation in Pregnancy

Selenium Supplementation Treatment in Euthyroid Pregnant Women With Autoimmune Thyroid Disease: Effects on Obstetrical Complications

TPOab and Tgab titers will be measured using a ECLIA kit. Plasma selenium concentration will also be measured

Also changes in thyroid nodules diameters and/or nodules formation will be measured by Ultrasonographic (US) imaging

Pre-eclampsia (gestational hypertension: systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation), Miscarriage, Placental Abruption, Abruption, Gestational hypertension, Breech presentation at birth, Preterm birth (< 37 weeks gestation), Symptomatic hypothyroidism, Preterm labour, Postpartum haemorrhage, Postpartum depression, Postpartum Thyroiditis, Maternal death

Small for gestational age, Admission to special care, Cretinism, Jaundice requiring phototherapy, Poor feeding, Constipation, Hoarse cry, Lethargy, Hypotonia, Macroglossia, Umbilical hernia

Quality of life will be measured by questionnaire SF12

Maternal length of hospital stay (days), Neonatal length of hospital stay (in days), Cost of services

Glucose, Vitamin B-12, folate, methionine, albumin and cytokines will be also measured in serum

thyroiditis/glutation

Selenium Supplementation in Youths With Autoimmune Thyroiditis

Selenium Supplementation in Pregnancy

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