Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

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.

Conditions

• Iodine Deficiency
• Infant Development

Interventions

DIETARY_SUPPLEMENT

Placebo

Daily placebo supplementation from enrolment \<14 wk of gestation until delivery

DIETARY_SUPPLEMENT

Iodine

Daily supplementation with 200 µg iodine from enrolment \<14 wk of gestation until delivery

Sponsors & Collaborators

• St. John's Research Institute

  collaborator OTHER

• Mahidol University

  collaborator OTHER

• Unilever R&D

  collaborator INDUSTRY

• Swiss National Science Foundation

  collaborator OTHER

• Nestlé Foundation

  collaborator OTHER

• Wageningen University

  lead OTHER

Principal Investigators

• Michael Zimmermann, Prof. dr. · Wageningen University

• Alida Melse-Boonstra, PhD · Wageningen University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2012-05-31

Completion

2016-05-31

Countries

• India
• Thailand

Study Locations