Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development (MITCH)
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.
|Iodine Deficiency Infant Development||Dietary Supplement: Placebo Dietary Supplement: Iodine|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development|
- 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 [ Time Frame: Child age 2-6 years ]Anthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds
|Study Start Date:||September 2008|
|Study Completion Date:||May 2016|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Dietary Supplement: Iodine
Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery
|Placebo Comparator: 2||
Dietary Supplement: Placebo
Daily placebo supplementation from enrolment <14 wk of gestation until delivery
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791466
|St. Johns Medical College and Research Institute|
|Bangalore, India, 560034|
|Insitute of Nutrition, Mahidol University (INMU)|
|Bangkok, Thailand, 73170|
|Principal Investigator:||Michael Zimmermann, Prof. dr.||Wageningen University|
|Principal Investigator:||Alida Melse-Boonstra, PhD||Wageningen University|