NCT00831402

Brief Summary

Goals of the study :

  1. 1.To study maternal thyroid function during pregnancy with or without supplementation with pregnancy tablets fortified with iodine
  2. 2.To establish reference values of thyroid function at different stages of pregnancy (3 trimesters)
  3. 3.To precise screening strategy of iodine deficiency in our population and suggest recommendation for its prevention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

January 28, 2009

Last Update Submit

March 26, 2026

Conditions

Pregnancy

Keywords

woman

Outcome Measures

Primary Outcomes (1)

  • • Intra individual variation of maternal thyroglobulin between the first trimester and the delivery • And cord blood thyroglobulin With comparison of the 2 groups (control and supplementation with iodine)

    Every 3 months up to the give birth, the day of a give birth, and after three months

Secondary Outcomes (1)

  • Comparison of control and treated groups for : • Frequence of miscarriage, duration of gestation, birth weight, APGAR, neonatal complications, Maternal thyroid function, Frequency of post partum thyroiditis,Cord blood thyroid function

    Every 3 months up to the give birth, the day of a give birth, and after three months

Study Arms (2)

Arm without iodized vitamin (VITAMIN OLIGOBS PREGNANCY)

OTHER

50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)

Dietary Supplement: controll group

Arm with iodized vitamin

ACTIVE COMPARATOR

The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)

Dietary Supplement: Oligobs Maxiode

Interventions

Oligobs MaxiodeDIETARY_SUPPLEMENT

The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)

Arm with iodized vitamin
controll groupDIETARY_SUPPLEMENT

50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)

Arm without iodized vitamin (VITAMIN OLIGOBS PREGNANCY)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All women follow-up in the three months of the pregnancy in the CHU de Nice
  • Maternal thyroid function is between and 0.1\<TSH\<2.5 mUI/l, 23\>T4L\>12 pmol/l
  • Person over 18
  • Signed lit Consent
  • Give birth in the CHU of Nice

You may not qualify if:

  • Allergy known in iodine
  • Iodized surcharge defined by an iodurie\> 400 mcg / l
  • Catch of ongoing iodized vitamins of pregnancy
  • Participation in another research protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Nice, Alpes-Maritimes, 06001, France

Location

Related Publications (1)

  • Brucker-Davis F, Ganier-Chauliac F, Gal J, Panaia-Ferrari P, Pacini P, Fenichel P, Hieronimus S. Neurotoxicant exposure during pregnancy is a confounder for assessment of iodine supplementation on neurodevelopment outcome. Neurotoxicol Teratol. 2015 Sep-Oct;51:45-51. doi: 10.1016/j.ntt.2015.07.009. Epub 2015 Aug 4.

    PMID: 26247661RESULT

Study Officials

  • Françoise Dr BRUCKER-DAVIS, PH

    CHU de Nice - Service d'endocrinologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

June 1, 2007

Primary Completion

July 1, 2007

Study Completion

August 1, 2008

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)