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Completed

NCT Number: NCT02610959

Iodine Status During Pregnancy and Its Effect on Infant Development.

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.

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Key information

Conditions

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Marine Research

Bergen, 5817, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention group

Other

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

Other

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.

Primary outcomes

  1. Difference in Urinary iodine concentration between groups

    Time frame: 16 weeks

    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.

Secondary outcomes

  1. Difference in Bayley Scale of Infant Developmental scores between groups

    Time frame: 17 months

    Student's t-test to compare the means between the groups.

Other outcomes

  1. Difference in Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)

    Time frame: Infant age 3, 6 and 11 months

    We compare scores between groups using linear mixed effects models and examined whether iodine status post intervention mediated the effect on child development.

  2. Difference in Ages and Stages Questionnaire 2nd. edition (ASQ-2)

    Time frame: Infant age 3, 6 and 11 months

    We compare scores between groups using linear mixed effects models and examined whether iodine status post intervention mediated the effect on child development.

  3. Extended follow up at five-six years - 5-15R (FTF/Five To Fifteen) questionnaire

    Time frame: Child age five-six years

    We compare scores between groups 5-15R (FTF/Five To Fifteen) questionnaire

  4. Extended follow up at five-six years - Difference in Ages and Stages Questionnaire Social-Emotional (ASQ:SE)

    Time frame: Child age five-six years

    We compare scores between groups in Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)

  5. Extended follow up at five-six years - Strengths and Difficulties Questionnaire

    Time frame: Child age five-six years

    We compare scores between groups in Strengths and Difficulties Questionnaire

Sponsors and collaborators

Lead sponsor

National Institute of Nutrition and Seafood Research, Norway

Other Gov

Collaborators

  • NORCE Norwegian Research Centre AS

Registry information

Official study title

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

Acronym: Mommy'sFood

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2015
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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