Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes (IODIAB)

Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Evaluation of iodine supplementation

Detailed Description

Physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. The iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. The general French population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. However, according to French studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. To maintain euthyroidism, the mother must increase her T4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d The thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. Our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Corbeil-essonnes, France, 91106
    • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women with gestational diabetes

Description

Inclusion Criteria:

• pregnant woman with gestational diabetes
• age ≥ 18 years
• subject informed of the study and not having opposed it.

Exclusion Criteria:

• already known pathology of the thyroid

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iodine supplementation	µg/day	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: gestational diabetes; Iodine intake; iodine supplementation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: IDRCB 2020-A02570-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No