Safety and Efficacy of Iodine Supplementation During Pregnancy With and Without Selenium Co-administration: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in anti-TPO Ab
研究概览
简要总结
In 1994, the WHO and UNICEF Joint Committee on Health Policy recommended Universal Salt Iodization as a safe, cost-effective and sustainable strategy to ensure sufficient intake of iodine by all individuals. However, it is still absent in Latvia.
A recent countrywide study in 2013 shows iodine deficiency among pregnant women in Latvia: 81 % of pregnant women had UIC levels below the WHO recommended range of 150-250 mcg/g Cr.
Because mild to moderate iodine deficiency during pregnancy can adversely affect fetal brain development, WHO-UNICEF and ICCIDD advise an increase in the recommended daily dosage of iodine to 250 mcg/day for pregnant women and breastfeeding women and 150 mcg/day for women in the preconception period.
Data from a survey of the Latvian population indicate that approximately 100 mcg of iodine per day is consumed through foods and iodized salt. To meet the increased iodine requirement in pregnancy, pregnant women should take a supplement containing 150 mcg of iodine daily from the earliest time possible.
A sudden increase in iodine intake in an iodine-deficient population may increase thyroid autoimmunity. It is evident that thyroid disease has multiple adverse effects during pregnancy and in the developing fetus especially in women with elevated serum anti-thyroid antibody titers.
Studies have considered supplementing with selenium to reduce the risk of auto-immune thyroiditis/post-partum autoimmune thyroid disease. Of the 11 trials of selenium supplementation in patients with autoimmune thyroiditis, 7 have shown benefit with treatment for 6 months or longer.
Aim of study is to approve that 150 mcg of iodine daily improves iodine status in pregnant women and iodine 150 mcg in combination with selenium 100 mcg daily reduce risk of thyroid autoimmunity.
Hypothesis of study is that 150 mcg iodine daily during pregnancy improves iodine status. Iodine in combination with selenium is less associated with thyroid autoimmunity.
Study design: Pregnant women are randomized for either 150 mcg iodine intake daily or 150 mcg iodine combined with 100 mcg selenium daily. Interventional group is compared with controls without particular iodine supplementation.
Participants are asked to complete a questionnaire on dietary habits concerning iodine. Thyroid function (thyroid-stimulating hormone, free thyroxine) and thyroperoxidase antibodies (TPO-Ab) and urinary iodine are measured during first, second and third trimester of pregnancy and week 8 after delivery in both, intervention and control group.
详细描述
In 1994, the WHO and UNICEF Joint Committee on Health Policy recommended Universal Salt Iodization as a safe, cost-effective and sustainable strategy to ensure sufficient intake of iodine by all individuals. However, universal salt iodization is still absent in Latvia.
A recent countrywide study in 2013 shows iodine deficiency among pregnant women in Latvia. The median Cr-standardized UIC was 80.8 (interquartile range (IQR) 46.1-130.6) mcg/g Cr or 69.4 (IQR 53.9-92.6) mcg/L during pregnancy, and 81 % of pregnant women had UIC levels below the WHO recommended range of 150-250 mcg/g Cr.
Because mild to moderate iodine deficiency during pregnancy can adversely affect fetal brain development, WHO-UNICEF and ICCIDD advise an increase in the recommended daily dosage of iodine to 250 mcg/day for pregnant women and breastfeeding women and 150 mcg/day for women in the preconception period.
Data from a survey of the Latvian population indicate that approximately 100 mcg of iodine per day is consumed through foods and iodized salt. To meet the increased iodine requirement in pregnancy, pregnant women should take a supplement containing 150 mcg of iodine daily from the earliest time possible.
A sudden increase in iodine intake in an iodine-deficient population may increase thyroid autoimmunity. Studies have connected induction of disease processes with thyroglobulin (Tg) iodination, because hypo-iodinated Tg did not activate T cells; however, increasing the Tg iodine content to even normal levels in vitro led to antigenicity of the molecule. It is evident that thyroid disease has multiple adverse effects during pregnancy and the postpartum period, and in the developing fetus especially in women with elevated serum anti-thyroid antibody titers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women before 10 weeks of gestation
- •signed informed consent form
排除标准
- •pre-existing thyroid disease
- •pregnancy after assisted reproductive technologies
- •known hypersensitivity reaction to iodine or selenium, or other components of dietary supplement used in the study
研究组 & 干预措施
Control
Without additional iodine supplementation.
Iodine + Selenium
Receiving iodine and selenium.
干预措施: Iodine + Selenium (Dietary Supplement)
Iodine
Receiving iodine.
干预措施: Iodine (Dietary Supplement)
结局指标
主要结局
Change in anti-TPO Ab
时间窗: At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample)
Change in anti-thyroperoxidase antibodies
UIC
时间窗: At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample)
Urinary iodine concentration
次要结局
- TSH(At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample))
- fT4(At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample))
研究者
Ilze Konrade
associate professor
Riga Stradins University