Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

Study Overview
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Brief Summary
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Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of their offspring. However, the potential adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear. Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in iodine deficiency. Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid function, pregnancy outcome, birth weight, infant growth and cognitive performance. Study design: Double-blind randomized controlled multicentre trial. Study population: Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be recruited at two research sites, namely St. Martha's hospital in Bangalore, India and Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be recruited. Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and the other half to placebo throughout pregnancy. Main study parameters/endpoints: Differences between group means in indicators of thyroid function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor development.

Official Title
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Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development

Conditions
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Iodine Deficiency, Infant Development

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Iodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-40 years; Gestational age: ≤ 14 weeks (as judged by the date of the last menstrual period); Single pregnancy; Non-lactating; Planned residence in the area for the duration of the study (3 years). Exclusion Criteria: TSH levels outside the normal range History of serious medical conditions such as HIV, hypertension, diabetes, renal, hepatic or cardiovascular disease, thyroid disorders, mental disorders; Use of iodine supplement.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Iodine<br>* Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo<br>* Daily placebo supplementation from enrolment <14 wk of gestation until delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current primary outcome: Infant cognitive and motor development |  | Regular intervals up till 6 years of age | 
| Original primary outcome: Maternal thyroid function |  | 3-month intervals during pregnancy, at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth outcome |  | At delivery | 
| Maternal and infant urinary iodine |  | Regular intervals during pregnancy up till 2 years after delivery | 
| Breast milk iodine |  | 3 and 6 months after delivery | 
| Long-term follow up | Anthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds | Child age 2-6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iodine deficiency, Pregnancy, Thyroid function, Infant development, Growth