Preventing Lack of Iodine During Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00379535
• Other study ID #: 0501101
• Secondary ID: PHRC
• Status: Terminated
• Phase: Phase 3
• First received: September 21, 2006
• Last updated: October 10, 2011
• Start date: December 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2011
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 "

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 374
• Est. completion date: June 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• potassium iodide
per os
• placebo
per os

Locations

Country	Name	City	State
France	Endocrinology - University Hospital	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Prevalence of hypothyroxinemia and hypothyroidism during pregnancy		9 months max	No
Secondary	Change in the functional thyroid parameters of mother during iodine treatment		2 years	No
Secondary	Comparison of the psychometric development of children , for woman with and without treatment		6, 12, and 24 months	Yes
Secondary	Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment		3 months	No