Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development (MITCH)
|ClinicalTrials.gov Identifier: NCT00791466|
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : November 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Iodine Deficiency Infant Development||Dietary Supplement: Placebo Dietary Supplement: Iodine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||829 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2016|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|