Potential Preventive Effect of Selenium on Iodine-induced Thyroid Autoimmunity During Pregnancy
NCT03377218 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2018-04-19
Summary
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.
Conditions
- Pregnancy
- Thyroid Autoimmune Disease
- Iodine Deficiency
- Selenium Deficiency
Interventions
- DIETARY_SUPPLEMENT
-
Iodine
Receiving 150 μg iodine (as potassium iodide) daily
- DIETARY_SUPPLEMENT
-
Iodine + Selenium
Receiving a combination of 150 μg iodine (as potassium iodide) and 100 μg selenium daily
Sponsors & Collaborators
-
Latvian Biomedical Research and Study Centre
collaborator OTHER_GOV -
Riga Maternity hospital
collaborator UNKNOWN -
Latvian Institute of Organic Synthesis
collaborator OTHER -
Riga Stradins University
lead OTHER
Principal Investigators
-
Ilze Konrade, professor · Riga Stradins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-01-05
- Primary Completion
- 2018-12-31
- Completion
- 2019-01-31
Countries
- Latvia
Study Locations
More Related Trials
-
Acceptability and Nutritional Impact of Double-fortified Salt Containing Iodine and Folic Acid
NCT06223854 ·Status: COMPLETED ·Phase: NA
-
Nutritional Status and Iodized Salt Use Among School-aged Children
NCT05862376 ·Status: COMPLETED
-
An Iodine Balance Experiment
NCT03279315 ·Status: COMPLETED ·Phase: NA
-
Using Iodized Salt to Improve Serum Folate, B12 and Iron Levels
NCT06904612 ·Status: COMPLETED
-
Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months
NCT02280330 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment
NCT05901766 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Acceptability and Nutritional Impact of Double-fortified Salt Containing Iodine and Folic Acid - Phase 1
NCT05792241 ·Status: COMPLETED
-
Distribution of Fortified Yoghurt in Senegal to Decrease Children's Anemia and Improve Milk Supply
NCT02079961 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Study on Dietary Intake Levels of Iodine for 3-6 Years Old Pre-school Children
NCT06074770 ·Status: RECRUITING
-
Study of the Effect of Iodized Oil Supplementation During Infancy
NCT01126125 ·Status: COMPLETED ·Phase: NA
-
RCT of Iodine-containing MNPs vs Oral Iodized Oil to Prevent Iodine Deficiency in Weaning Infants
NCT02421653 ·Status: WITHDRAWN ·Phase: NA
-
Vitamin A Total Body Stores of Senegalese Children in Relation to Their Infectious Status
NCT03207308 ·Status: COMPLETED ·Phase: NA
-
Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants
NCT02066610 ·Status: COMPLETED ·Phase: NA
-
Nutrition Behavior on Micronutrient Among Growth Children in Central Highland of Ethiopia: Cluster Randomized Trial.
NCT04846062 ·Status: UNKNOWN ·Phase: NA
-
Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
NCT00944359 ·Status: COMPLETED ·Phase: NA
-
Establishing the Iodine Requirement in Infancy
NCT02045784 ·Status: COMPLETED ·Phase: NA
-
Iodine Status in Portuguese Children and the Role of Salt Fortification in School Canteens
NCT02608138 ·Status: COMPLETED
-
Efficacy of Double Fortified Salt (DFS) to Improve Work Productivity in Women in India
NCT01032005 ·Status: COMPLETED ·Phase: NA
-
The Efficacy of Zinc-biofortified Rice in Bangladeshi Children
NCT03079583 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
NCT00980733 ·Status: UNKNOWN ·Phase: PHASE3
-
Sustainable Intervention of Supplementation to Improve Kid's Growth Study
NCT04564222 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Trial of Thiamine Supplementation in Cambodia
NCT03616288 ·Status: COMPLETED ·Phase: NA
-
Is Iron Deficiency the Cause of Anemia Among Women in Cambodia?
NCT02481375 ·Status: COMPLETED ·Phase: NA
-
Multiple Micronutrient Supplementation vs Iron and Folic Acid Among Pregnant Women in Cambodia
NCT05867836 ·Status: COMPLETED ·Phase: NA
-
Zinc Absorption From Zinc Biofortified Rice in Bangladeshi Children
NCT04099849 ·Status: UNKNOWN ·Phase: NA