Iodine Status During Pregnancy and Its Effect on Infant Development.

Diet Clinical Trial

— Mommy'sFood  

Official title:

Iodine Status During Pregnancy and Its Effect on Infant Development; a Randomized Intervention Study With Cod

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610959
• Other study ID #: 2015/879
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: September 17, 2018

Study information

• Verified date: April 2023
• Source: National Institute of Nutrition and Seafood Research, Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim of the present project is to investigate if intake of cod in pregnancy has impact on infant development up to 12 month. 142 pregnant women will be allocated into two groups, one counsuming cod two times the week for four months and one group will continue to follow their habitual diet. To study this, urine samples, dietary data and blood samples from the mother and from the infant, as well as data on neurodevelopment and cognitive functioning will be collected at several time points.

Description:

The World Health Organization considers iodine deficiency to be "the single most important preventable cause of brain damage" worldwide. The effect of severe iodine deficiency is well documented. Pregnant and nursing mothers have increased requirements and are thus a vulnerable group. Iodine is a key component of thyroid hormones that are critical for normal development of the brain and nervous system in utero. There is little data on the effect of mild- and moderate iodine deficiency. Results from the Norwegian Mother and Child cohort (n = about 62,000) shows that only 22% of the participants had an iodine intake, estimated from food frequency questionnaire, that meets the recommendations of WHO / UNICEF / ICCIDD. Urine samples from a sub-sample (n = 119) confirmed suboptimal iodine status. The results are consistent with recent data from a NIFES study of about 100 women from the municipality of Fjell, which reviled suboptimal iodine status both in pregnancy and three months after birth. Preliminary results from the study Little in Norway, where NIFES measured the iodine status in approximately 1,000 pregnant from across the country, is also consistent with these investigations. Dairy products is highlighted as the main source of iodine for the participants in the Norwegian Mother and Child cohort, while lean fish is the food group that has the highest Iodine levels. In this article, the positive effect of seafood was explained by the fatty acids EPA and DHA, while the latest publication suggests that the effect of an adequate intake of seafood during pregnancy are more complex, and that the high iodine levels in seafood may also be important. Based on this knowledge, there is a need for an intervention study where pregnant consume cod regularly over a longer period and where the children are followed up over time. Thus, in the present project the researchers will investigate if intake of cod in pregnancy has impact on infant development up to 12 month. 142 pregnant women will be allocated into two groups, one consuming cod two times the week for four months and one group will eat as normal. Urine samples, dietary data and blood samples from the mother and from the infant, as well as data on neurodevelopment and cognitive functioning will be collected at several time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: September 17, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• = gestational week 19,

• prim parous,

• singleton pregnancy,

• Norwegian speaking and / or understand Norwegian writing due to all validated tests of the child will be in Norwegian.

Exclusion Criteria:

• allergies to fish,

• chronic diseases known to affect iodine status (Graves' disease, Thyroiditis, Thyroid Nodules, known hypothyroidism, known hyperthyroidism).

Related Conditions & MeSH terms

• Diet
• Neurodevelopment

Intervention

Other:
• Intervention group
The overall aim of the present project is to investigate if intake of cod in pregnancy has impact on infant development up to 12 month.
• Control group
The overall aim of the present project is to investigate if intake of cod in pregnancy has impact on infant development up to 12 month.

Locations

Country	Name	City	State
Norway	Institute of Marine Research	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Nutrition and Seafood Research, Norway	NORCE Norwegian Research Centre AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)	We compare scores between groups using linear mixed effects models and examined whether iodine status post intervention mediated the effect on child development.	Infant age 3, 6 and 11 months
Other	Difference in Ages and Stages Questionnaire 2nd. edition (ASQ-2)	We compare scores between groups using linear mixed effects models and examined whether iodine status post intervention mediated the effect on child development.	Infant age 3, 6 and 11 months
Other	Extended follow up at five-six years - 5-15R (FTF/Five To Fifteen) questionnaire	We compare scores between groups 5-15R (FTF/Five To Fifteen) questionnaire	Child age five-six years
Other	Extended follow up at five-six years - Difference in Ages and Stages Questionnaire Social-Emotional (ASQ:SE)	We compare scores between groups in Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)	Child age five-six years
Other	Extended follow up at five-six years - Strengths and Difficulties Questionnaire	We compare scores between groups in Strengths and Difficulties Questionnaire	Child age five-six years
Primary	Difference in Urinary iodine concentration between groups	A collection sample of 1 ml of homogenized spot morning urin collected on six consecutive days will be analyzed for iodine (umol/L) before and after the intervention in both Groups. Groups will be compared in relation to delta-values before and after intervention/no intervention.	16 weeks
Secondary	Difference in Bayley Scale of Infant Developmental scores between groups	Student's t-test to compare the means between the groups.	17 months