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

November 13, 2008
January 29, 2013
September 2008
May 2012   (final data collection date for primary outcome measure)
Maternal thyroid function [ Time Frame: 3-month intervals during pregnancy, at delivery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791466 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development
Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Iodine Deficiency
  • Infant Development
  • 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
  • Experimental: 1
    Intervention: Dietary Supplement: Iodine
  • Placebo Comparator: 2
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
December 2013
May 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand,   India
 
NCT00791466
MITCH-01
Yes
Alida Melse, Wageningen University
Wageningen University
  • St. John's Research Institute
  • Mahidol University
  • Unilever R&D
  • Swiss National Science Foundation
  • Nestlé Foundation
Principal Investigator: Michael Zimmermann, Prof. dr. Wageningen University
Principal Investigator: Alida Melse-Boonstra, PhD Wageningen University
Wageningen University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP