Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

NCT00791466 | Completed DMC

• 1 other identifier: MITCH-01
• Study Type: interventional
• Target: 829
• Locations: 2 countries
• Sites: 2

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.

Conditions

Iodine Deficiency; Infant Development

Keywords

Iodine deficiency; Pregnancy; Thyroid function; Infant development; Growth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Dietary Supplement: Iodine

2

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

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

2

Iodine DIETARY_SUPPLEMENT

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

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wageningen University: lead
• St. John's Research Institute: collaborator
• Mahidol University: collaborator
• Unilever R&D: collaborator
• Swiss National Science Foundation: collaborator
• Nestlé Foundation: collaborator

Study Sites (2)

St. Johns Medical College and Research Institute

Bangalore, 560034, India

Location

Insitute of Nutrition, Mahidol University (INMU)

Bangkok, 73170, Thailand

Location

Related Publications (5)

• Melse-Boonstra A, Gowachirapant S, Jaiswal N, Winichagoon P, Srinivasan K, Zimmermann MB. Iodine supplementation in pregnancy and its effect on child cognition. J Trace Elem Med Biol. 2012 Jun;26(2-3):134-6. doi: 10.1016/j.jtemb.2012.03.005. Epub 2012 May 8.

  PMID: 22575544 BACKGROUND

• Gowachirapant S, Melse-Boonstra A, Winichagoon P, Zimmermann MB. Overweight increases risk of first trimester hypothyroxinaemia in iodine-deficient pregnant women. Matern Child Nutr. 2014 Jan;10(1):61-71. doi: 10.1111/mcn.12040. Epub 2013 Aug 13.

  PMID: 23937433 BACKGROUND

• Jaiswal N, Melse-Boonstra A, Thomas T, Basavaraj C, Sharma SK, Srinivasan K, Zimmermann MB. High prevalence of maternal hypothyroidism despite adequate iodine status in Indian pregnant women in the first trimester. Thyroid. 2014 Sep;24(9):1419-29. doi: 10.1089/thy.2014.0071. Epub 2014 Jul 21.

  PMID: 24923842 BACKGROUND

• Gowachirapant S, Jaiswal N, Melse-Boonstra A, Galetti V, Stinca S, Mackenzie I, Thomas S, Thomas T, Winichagoon P, Srinivasan K, Zimmermann MB. Effect of iodine supplementation in pregnant women on child neurodevelopment: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):853-863. doi: 10.1016/S2213-8587(17)30332-7. Epub 2017 Oct 10.

  PMID: 29030199 BACKGROUND

• Verhagen NJE, Gowachirapant S, Winichagoon P, Andersson M, Melse-Boonstra A, Zimmermann MB. Iodine Supplementation in Mildly Iodine-Deficient Pregnant Women Does Not Improve Maternal Thyroid Function or Child Development: A Secondary Analysis of a Randomized Controlled Trial. Front Endocrinol (Lausanne). 2020 Oct 6;11:572984. doi: 10.3389/fendo.2020.572984. eCollection 2020.

  PMID: 33123091 BACKGROUND

MeSH Terms

Interventions

Iodine

Intervention Hierarchy (Ancestors)

Halogens; Elements; Inorganic Chemicals

Study Officials

• Michael Zimmermann, Prof. dr.

  Wageningen University

  PRINCIPAL INVESTIGATOR

• Alida Melse-Boonstra, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2016
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

IN (1); TH (1)