Iodine Supplementation During Pregnancy and Neuropsychological Development

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01049659
First received: January 12, 2010
Last updated: December 8, 2011
Last verified: December 2011

January 12, 2010
December 8, 2011
February 2010
June 2011   (final data collection date for primary outcome measure)
neuropsychological test [ Time Frame: one time mesure- just one visit in the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01049659 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Iodine Supplementation During Pregnancy and Neuropsychological Development
Effect of Iodine Supplementation and During Pregnancy on Neuropsychological Development of Children Assessed at 2 Years Old

The investigators have shown that Nice area, like most of France, remains an area of mild iodine deficiency. The investigators want to assess the potential benefit of early iodine supplementation during pregnancy in women with normal thyroid function on the neuropsychological development of their children assessed at the age of two with the Bayley test.

Iodine is required for the synthesis of thyroid hormones. During pregnancy, iodine needs are increased to cover maternal and fetal thyroid hormones synthesis and the increased renal iodine clearance. Maternal hypothyroidism and/or severe iodine deficiency are associated to mental retardation in their offspring. Indeed, thyroid hormones and iodine are necessary for fetal brain development.

Iodine deficiency remains the first cause of preventable mental retardation. In France, preventive programs with salt iodine fortification are insufficient to eradicate iodine deficiency. In previous studies, we have shown that iodine deficiency is the rule for pregnant women in our area: 66 to 85% of women tested depending on the stage of pregnancy (Brucker-Davis 2004, Hieronimus et al 2009, abstract at the 2008 ETA and SFE meetings, article in preparation reporting results from our 2006 PHRC: Study of thyroid function during pregnancy with or without iodine supplementation).We will study the impact of early iodine supplementation in normal pregnant women on the neuropsychological development of their offspring assessed at 2 years of age. This is the follow-up of a cohort of children born to women enrolled in our 2006 PHRC. 110 healthy women have been included in this prospective study: they were seen early (median 8 weeks of gestation) and had strictly normal thyroid function tests, as well as no personal thyroid history. They were randomized into two groups: group A taking pregnancy vitamins without iodine supplementation (Oligobs GrossesseR 2 tablets/day) our group B taking the same vitamins but iodine fortified (Oligobs MaxiodeR 2 tablets per day, i.e. 150 mcg of iodine/day).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Healthy
  • Iodine Deficiency
  • Pregnancy
Behavioral: Neuropsychological test
Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old
neuropsychological tests
neuropsychological assessment of children around their second birthday
Intervention: Behavioral: Neuropsychological test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • children which mother were included in the precedent protocol(pregnancy vitamins with or without iodine)

Exclusion Criteria:

  • children of more of 25 months old
  • children with acute pathology
  • children with chronic pathology
Both
23 Months to 25 Months
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01049659
09-PP-04
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Françoise BRUCKER-DAVIS, PhD Nice University Hospital
Principal Investigator: Sylvie HIERONIMUS, PhD Nice University Hospital
Centre Hospitalier Universitaire de Nice
December 2011

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