NCT00162539

Brief Summary

Mother with severe Iodine deficiency are more likely to have neonates with further poor mental development . In order to select population which could benefit from iodine supplementation, ioduria has been tested but cannot be routinely practised. Strong background data suggest that iodine status could be antenatally correlated with foetal thyroid volume. The aim of that study is to examine correlation between these two parameter in a population of 130 healthy pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 26, 2012

Status Verified

May 1, 2005

Enrollment Period

8 months

First QC Date

September 10, 2005

Last Update Submit

July 25, 2012

Conditions

Deficiency Disease

Keywords

foetal thyroid mensuration

Outcome Measures

Primary Outcomes (1)

  • establish a relationship between maternal urinary iodine and thyroid measurements of fetal

    final time frame at the end of the study

Interventions

echographyOTHER

Correlation of neonatal thyroid volume with maternal iodine deficiency

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • normal single pregnancy in a healthy volunteer

You may not qualify if:

  • any associated disease
  • pertubation of thyroid status at 12 GA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Beaujon

Paris, 92110, France

Location

Related Publications (1)

  • Luton D, Alberti C, Vuillard E, Ducarme G, Oury JF, Guibourdenche J. Iodine deficiency in northern Paris area: impact on fetal thyroid mensuration. PLoS One. 2011 Feb 16;6(2):e14707. doi: 10.1371/journal.pone.0014707.

    PMID: 21359193DERIVED

MeSH Terms

Conditions

Deficiency Diseases

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Dominique LUTON

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 13, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

July 26, 2012

Record last verified: 2005-05

Locations

FR(1)