Selenium supplementation in the management of thyroid autoimmunity during pregnancy: results of the "SERENA study", a randomized, double-blind, placebo-controlled trial.

2019-05-25
Endocrine 66(3)
- G Mantovani
- A M Isidori
- C Moretti
- C Di Dato
- E Greco
- P Ciolli
- M Bonomi
- L Petrone
- A Fumarola
- G Campagna
- G Vannucchi
- S Di Sante
- C Pozza
- A Faggiano
- A Lenzi
- E Giannetta

PubMed: 31129812
DOI: 10.1007/s12020-019-01958-1

Study Design

Type: Randomized Controlled Trial (RCT)
Population: Forty-five women with thyroiditis in pregnancy
Methods: multicenter, randomized, double-blind, placebo-controlled trial, L-selenomethionine 83 mcg/day or placebo
Blinding: Double-blind
Funding: Independent

Purpose

Selenium is frequently in nutraceuticals for pregnancy, given its role on fertility and thyroid metabolism. However, most evidence rise from non-controlled studies. We aimed to evaluate the protective effect of selenium against thyroid autoimmunity during and after pregnancy.

Methods

A multicenter, randomized, double-blind, placebo-controlled trial was performed and promoted by the Young Italian Endocrinologists Group (EnGioI)-Italian Society of Endocrinology. Forty-five women with thyroiditis in pregnancy were enrolled and randomly assigned to L-selenomethionine (L-Se-Met) 83 mcg/day or placebo (PLB) and evaluated at 10 ± 2 (T1), 36 ± 2 weeks of gestation (T2) and 6 months after delivery (postpartum, PP).

Results

We measured a significant reduction of autoantibodies after pregnancy in L-Se-Met group [at PP: TgAb 19.86 (11.59-52.60), p < 0.01; TPOAb 255.00 (79.00-292.00), p < 0.01], and an antibodies titer's rebound in PLB group (TgAb 151.03 ± 182.9, p < 0.01; TPOAb 441.28 ± 512.18, p < 0.01). A significant increase in selenemia was measured in L-Se-Met group at T2 (91.33 ± 25.49; p < 0.01) and PP (93.55 ± 23.53; p = 0.02). Two miscarriage occurred in PLB. No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.

Conclusions

SERENA study demonstrated a beneficial effect of L-Se-Met supplementation on autoantibody titer during pregnancy and on postpartum thyroiditis recurrence.

Research Insights

L-Selenomethionine→Improved Quality of Life
No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.
Effect
Neutral
Effect size
Small
Dose
83 mcg/day
L-Selenomethionine→Improved Thyroid Echogenicity
No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.
Effect
Neutral
Effect size
Small
Dose
83 mcg/day
L-Selenomethionine→Increased Selenium Level
A significant increase in selenemia was measured in L-Se-Met group at T2 (91.33 ± 25.49; p < 0.01) and PP (93.55 ± 23.53; p = 0.02)
Effect
Beneficial
Effect size
Moderate
Dose
83 mcg/day
L-Selenomethionine→Increased Selenium Status
A significant increase in selenemia was measured in L-Se-Met group at T2 (91.33 ± 25.49; p < 0.01) and PP (93.55 ± 23.53; p = 0.02).
Effect
Beneficial
Effect size
Moderate
Dose
83 mcg/day
L-Selenomethionine→Reduced Fetal Complication
No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.
Effect
Neutral
Effect size
Small
Dose
83 mcg/day
L-Selenomethionine→Reduced Maternal Complication
No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.
Effect
Neutral
Effect size
Small
Dose
83 mcg/day
L-Selenomethionine→Reduced Maternal-Fetal Complications
No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.
Effect
Neutral
Effect size
Small
Dose
83 mcg/day
L-Selenomethionine→Reduced Thyroglobulin Antibody Level
We measured a significant reduction of autoantibodies after pregnancy in L-Se-Met group [at PP: TgAb 19.86 (11.59-52.60), p < 0.01; TPOAb 255.00 (79.00-292.00), p < 0.01]
Effect
Beneficial
Effect size
Moderate
Dose
83 mcg/day
L-Selenomethionine→Reduced Thyroid Echogenicity
No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.
Effect
Neutral
Effect size
Small
Dose
83 mcg/day
L-Selenomethionine→Reduced Thyroid Peroxidase Antibody Level
We measured a significant reduction of autoantibodies after pregnancy in L-Se-Met group [at PP: TgAb 19.86 (11.59-52.60), p < 0.01; TPOAb 255.00 (79.00-292.00), p < 0.01]
Effect
Beneficial
Effect size
Moderate
Dose
83 mcg/day
L-Selenomethionine→Reduced Thyroid Volume
No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications.
Effect
Neutral
Effect size
Small
Dose
83 mcg/day