Selenium and vitamin D in the treatment of thyroid hormone excess

Effects of Selenium and cholecalciferol on hyperthyroidism due to Graves' disease treated with methimazole: a randomized, clinical, open label, pilot trial - SeMMIviD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005050-11-IT

Enrollment

Registered

2021-09-06

Start date

2019-03-08

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Graves' disease MedDRA version: 20.0 Level: PT Classification code 10020850 Term: Hyperthyroidism System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: DIBASE - 300.000 UI/ML SOLUZIONE INIETTABILE PER USO ORALE E INTRAMUSCOLARE 2 FIALE 1 ML Product Name: DIBASE Pharmaceutical Form: Oral solution Trade Name: DIBASE - 10.000 UI/ML GOCC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Hyperthyroidism due to Basedow disease -selenium and Vitamin D deficiency -age 18-70 years; Caucasian race -no concomitant major cardiovascular, haepatic, haemopoietic disease -vitamin D malabsorption (intestinal inflammatory chronic diseases, alcoholism, cystic fibrosis) - II-III grade obesity - no concomitant supplementation with vitamin D and/or Selenium -informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: intolerance to methimazole intolerance to Selenium (actually not known), or to excipients of Syrel concomitant conditions interfering with vitamin D metabolism (such as primary hyperparathyroidism, a granulomatous disease, kidney stones, some types of kidney disease, digital therapy -.pregnancy, breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the efficacy of concomitant therapy of Selenium and cholecalciferol in association to the standard therapy with methimazole to treat hyperthyroidism due to Grave's diseas after 180 days from enrollment. ;Secondary Objective: -To test the efficacy of concomitant therapy of Selenium and cholecalciferol in association to the standard therapy with metimazole to treat hyperthyroidism due to Grave's diseas after 45 and 240 days from enrollment. -To test parameters of oxidative metabolism and t reg profile as possible indicator of efficacy --Mean dose of methimazole - Ultrasound thyroid morphology/echogenicity;Primary end point(s): Biochimical and Clinical manifestation of hyperthyroid after 180 days from baseline. A difference of 3 pg/ml in FT4 levels after 180 days between the treatment group and the standard one is expected. -severity of hyperthyroidism assesed with Clinical Severity Score -Thyroid hormone levels (FT4, FT3, TSH) after 180 days from enrollment -Mean dose of methimazole;Timepoint(s) of evaluation of this end point: 180 days (T2)	—

Measure

Time frame

Main Objective: To test the efficacy of concomitant therapy of Selenium and cholecalciferol in association to the standard therapy with methimazole to treat hyperthyroidism due to Grave's diseas after 180 days from enrollment. ;Secondary Objective: -To test the efficacy of concomitant therapy of Selenium and cholecalciferol in association to the standard therapy with metimazole to treat hyperthyroidism due to Grave's diseas after 45 and 240 days from enrollment. -To test parameters of oxidative metabolism and t reg profile as possible indicator of efficacy --Mean dose of methimazole - Ultrasound thyroid morphology/echogenicity;Primary end point(s): Biochimical and Clinical manifestation of hyperthyroid after 180 days from baseline. A difference of 3 pg/ml in FT4 levels after 180 days between the treatment group and the standard one is expected. -severity of hyperthyroidism assesed with Clinical Severity Score -Thyroid hormone levels (FT4, FT3, TSH) after 180 days from enrollment -Mean dose of methimazole;Timepoint(s) of evaluation of this end point: 180 days (T2)

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Secondary

Measure	Time frame
Secondary end point(s): -clinical manifestation of hyperthyroid after 45 and 240 days from baseline -thyroid hormone levels (FT4, FT3, TSH) after 45 and 240 days from enrollment -severity of Graves' disease assessed by Clinical Severity Score assessed after 45 and 240 days from enrolment -Glutathione, Malondialdehyde levels baseline, after 180 and 240 days from enrolment -Lymphocytes typization for Treg baseline and after 180 days from enrollment - Ultrasound thyroid morphology/echogenicity ;Timepoint(s) of evaluation of this end point: day 45 (T0) and day 240 (T3)	—

Measure

Time frame

Secondary end point(s): -clinical manifestation of hyperthyroid after 45 and 240 days from baseline -thyroid hormone levels (FT4, FT3, TSH) after 45 and 240 days from enrollment -severity of Graves' disease assessed by Clinical Severity Score assessed after 45 and 240 days from enrolment -Glutathione, Malondialdehyde levels baseline, after 180 and 240 days from enrolment -Lymphocytes typization for Treg baseline and after 180 days from enrollment - Ultrasound thyroid morphology/echogenicity ;Timepoint(s) of evaluation of this end point: day 45 (T0) and day 240 (T3)

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Countries

Italy

Contacts

Public ContactSC Endocrinologia, ASST Sette Laghi

ASST Sette Laghi Varese

luigi.bartalena@uninsubria.it0332278325

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026