Preventing Lack of Iodine During Pregnancy

Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years

The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.

Study Overview

• Status: Terminated
• Conditions: Pregnancy
• Intervention / Treatment: Drug: potassium iodide; Drug: placebo

Detailed Description

374 patients with pregnancy less 12 weeks amenorrhea

Patients randomized in 2 parallel groups (each group with 187 patients)

• one group with 200 µg of potassium iodide
• one group with placebo

Follow up during 3 years with :

• a selection visit, an inclusion with randomization before 12 weeks amenorrhea
• and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and 6, 12, and 24 months " post partum "

• Study Type: Interventional
• Enrollment (Anticipated): 374
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Endocrinology - University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy, unique or twiny
• Patients who agree to take part in the study and able to sign an Informed Consent Form

Exclusion Criteria:

• Patients receiving a treatment for thyroid affection, or with thyroid pathology
• Patients with a chronic pathology like insulin dependent diabetes or arterial hypertension
• Patients with a treatment supplying iodine or having had a gynecologic exam with a iodine solution in the last 30 days
• Patients taking part in another clinical test or in the last 30 days
• Patients with depressive antecedent before pregnancy or taking antidepressant treatment
• Psychiatric troubles that may interfere with the clinical evaluation
• Patients under special supervision or trusteeship
• No social security cover

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Daily dose of 200 µg of potassium iodide	Drug: potassium iodide; per os; Other Names: Iodence
Placebo Comparator: 2; Daily dose of placebo	Drug: placebo; per os

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence of hypothyroxinemia and hypothyroidism during pregnancy	9 months max
Change in the functional thyroid parameters of mother during iodine treatment	2 years
Comparison of the psychometric development of children , for woman with and without treatment	6, 12, and 24 months
Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: CARON PHILIPPE, Pr, CHU Toulouse; Study Chair: WEMEAU Jean-Louis, Pr, CHRU Lille; Study Chair: NICCOLI-SIRE Patricia, Pr, CHU Timone MARSEILLE; Study Chair: BRUCKER-DAVIS Francoise, Dr, CHU Nice

Publications and helpful links

General Publications

• Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Ressigeac P, Vertongen F, Grange V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54. doi: 10.1089/thy.1997.7.749.
• Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: September 21, 2006
• First Submitted That Met QC Criteria: September 21, 2006
• First Posted (Estimate): September 22, 2006

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 10, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: pregnancy , lack of iodine; lack of iodine during pregnancy
• Other Study ID Numbers: 0501101; PHRC (2001/1939)