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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00379535

Enrollment

374

Registered

2006-09-22

Start date

2006-12-31

Completion date

2010-06-30

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

pregnancy , lack of iodine, lack of iodine during pregnancy

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.

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

Interventions

DRUGpotassium iodide

per os

DRUGplacebo

per os

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026