Iodine Supplementation During Pregnancy and Neuropsychological Development

Healthy Clinical Trial

Official title:

Effect of Iodine Supplementation and During Pregnancy on Neuropsychological Development of Children Assessed at 2 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049659
• Other study ID #: 09-PP-04
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: December 8, 2011
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Months to 25 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Iodine Deficiency
• Pregnancy

Intervention

Behavioral:
• Neuropsychological test
Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old

Locations

Country	Name	City	State
France	Endocrinology Department, Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropsychological test		one time mesure- just one visit in the study	No