Iodine Supplementation During Pregnancy and Neuropsychological Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01049659
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : December 9, 2011
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Iodine Deficiency Pregnancy Behavioral: Neuropsychological test Not Applicable

Detailed Description:

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Iodine Supplementation and During Pregnancy on Neuropsychological Development of Children Assessed at 2 Years Old
Study Start Date : February 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine
U.S. FDA Resources

Arm Intervention/treatment
neuropsychological tests
neuropsychological assessment of children around their second birthday
Behavioral: Neuropsychological test
Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old

Primary Outcome Measures :
  1. neuropsychological test [ Time Frame: one time mesure- just one visit in the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Months to 25 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01049659

Endocrinology Department, Nice University Hospital
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Principal Investigator: Françoise BRUCKER-DAVIS, PhD Nice University Hospital
Principal Investigator: Sylvie HIERONIMUS, PhD Nice University Hospital

Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT01049659     History of Changes
Other Study ID Numbers: 09-PP-04
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011

Keywords provided by Centre Hospitalier Universitaire de Nice:
iodine deficiency
neuropsychological development

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs