MITCH: Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

Sponsor

Wageningen University (Other)

Overall Status

Completed

CT.gov ID

NCT00791466

Collaborator

St. John's Research Institute (Other), Mahidol University (Other), Unilever R&D (Industry), Swiss National Science Foundation (Other), Nestlé Foundation (Other)

829

Enrollment

Locations

Arms

Duration (Months)

414.5

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

829 participants

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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

Arm

Intervention/Treatment

Experimental: 1

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

Outcome Measures

Primary Outcome Measures

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

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 [Child age 2-6 years]
Anthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.