Preventing Lack of Iodine During Pregnancy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Daily dose of 200 µg of potassium iodide |
Drug: potassium iodide
per os
Other Names:
|
| Placebo Comparator: 2 Daily dose of placebo |
Drug: placebo
per os
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
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Patients with depressive antecedent before pregnancy or taking antidepressant treatment
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Psychiatric troubles that may interfere with the clinical evaluation
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Patients under special supervision or trusteeship
-
No social security cover
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endocrinology - University Hospital | Toulouse | France | 31059 |
Sponsors and Collaborators
- University Hospital, Toulouse
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Réssigeac P, Vertongen F, Grangé 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.
- 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.
- 0501101
- PHRC