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Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development (MITCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. John's Research Institute
Mahidol University
Unilever R&D
Swiss National Science Foundation
Nestlé Foundation
Information provided by (Responsible Party):
Alida Melse, Wageningen University
ClinicalTrials.gov Identifier:
NCT00791466
First received: November 13, 2008
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Iodine Deficiency
Infant Development
 Dietary Supplement: Placebo
Dietary Supplement: Iodine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Maternal thyroid function [ Time Frame: 3-month intervals during pregnancy, at delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Birth outcome [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
  • Infant thyroid function [ Time Frame: Regular intervals up till 2 years of age ] [ Designated as safety issue: No ]
  • Infant cognitive and motor development [ Time Frame: Regular intervals up till 2 years of age ] [ Designated as safety issue: No ]
  • Maternal and infant urinary iodine [ Time Frame: Regular intervals during pregnancy up till 2 years after delivery ] [ Designated as safety issue: No ]
  • Breast milk iodine [ Time Frame: 3 and 6 months after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791466

Locations
India
St. Johns Medical College and Research Institute
Bangalore, India, 560034
Thailand
Insitute of Nutrition, Mahidol University (INMU)
Bangkok, Thailand, 73170
Sponsors and Collaborators
Wageningen University
St. John's Research Institute
Mahidol University
Unilever R&D
Swiss National Science Foundation
Nestlé Foundation
Investigators
Principal Investigator: Michael Zimmermann, Prof. dr. Wageningen University
Principal Investigator: Alida Melse-Boonstra, PhD Wageningen University
  More Information

No publications provided

Responsible Party: Alida Melse, Dr., Wageningen University
ClinicalTrials.gov Identifier: NCT00791466     History of Changes
Other Study ID Numbers: MITCH-01
Study First Received: November 13, 2008
Last Updated: January 29, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
India: Institutional Review Board
Thailand: Ethical Committee

Keywords provided by Wageningen University:
Iodine deficiency
Pregnancy
Thyroid function
Infant development
Growth

Additional relevant MeSH terms:
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013