Preventing Lack of Iodine During Pregnancy

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00379535
First received: September 21, 2006
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Pregnancy
Drug: potassium iodide
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prevalence of hypothyroxinemia and hypothyroidism during pregnancy [ Time Frame: 9 months max ] [ Designated as safety issue: No ]
  • Change in the functional thyroid parameters of mother during iodine treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Comparison of the psychometric development of children , for woman with and without treatment [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: Yes ]
  • Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 374
Study Start Date: December 2006
Study Completion Date: June 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Daily dose of 200 µg of potassium iodide
Drug: potassium iodide
per os
Other Name: Iodence
Placebo Comparator: 2
Daily dose of placebo
Drug: placebo
per os
Other Name: 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 "
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379535

Locations
France
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
  More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00379535     History of Changes
Other Study ID Numbers: 0501101, PHRC
Study First Received: September 21, 2006
Last Updated: October 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
pregnancy , lack of iodine
lack of iodine during pregnancy

Additional relevant MeSH terms:
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014