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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
829
St. Johns Medical College and Research Institute
Bangalore, India
Insitute of Nutrition, Mahidol University (INMU)
Bangkok, Thailand
Current primary outcome: Infant cognitive and motor development
Time frame: Regular intervals up till 6 years of age
Original primary outcome: Maternal thyroid function
Time frame: 3-month intervals during pregnancy, at delivery
Birth outcome
Time frame: At delivery
Maternal and infant urinary iodine
Time frame: Regular intervals during pregnancy up till 2 years after delivery
Breast milk iodine
Time frame: 3 and 6 months after delivery
Long-term follow up
Anthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds
Time frame: Child age 2-6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.