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Iodine Status During Pregnancy and Its Effect on Infant Development.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02610959
Acronym
Mommy'sFood
Enrollment
137
Registered
2015-11-20
Start date
2015-12-31
Completion date
2018-09-17
Last updated
2023-04-18

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

Conditions

Diet, Neurodevelopment

Brief 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.

Detailed 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.

Interventions

OTHERIntervention 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.

OTHERControl 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.

Sponsors

NORCE Norwegian Research Centre AS
CollaboratorOTHER
National Institute of Nutrition and Seafood Research, Norway
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Difference in Urinary iodine concentration between groups16 weeksA 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.

Secondary

MeasureTime frameDescription
Difference in Bayley Scale of Infant Developmental scores between groups17 monthsStudent's t-test to compare the means between the groups.

Other

MeasureTime frameDescription
Extended follow up at five-six years - 5-15R (FTF/Five To Fifteen) questionnaireChild age five-six yearsWe compare scores between groups 5-15R (FTF/Five To Fifteen) questionnaire
Difference in Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Infant age 3, 6 and 11 monthsWe compare scores between groups using linear mixed effects models and examined whether iodine status post intervention mediated the effect on child development.
Extended follow up at five-six years - Strengths and Difficulties QuestionnaireChild age five-six yearsWe compare scores between groups in Strengths and Difficulties Questionnaire
Extended follow up at five-six years - Difference in Ages and Stages Questionnaire Social-Emotional (ASQ:SE)Child age five-six yearsWe compare scores between groups in Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)
Difference in Ages and Stages Questionnaire 2nd. edition (ASQ-2)Infant age 3, 6 and 11 monthsWe compare scores between groups using linear mixed effects models and examined whether iodine status post intervention mediated the effect on child development.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026