Iodine Status During Pregnancy and Its Effect on Infant Development. (Mommy'sFood)

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

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.

Study Overview

• Status: Completed
• Conditions: Diet; Neurodevelopment
• Intervention / Treatment: Other: Intervention group; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5817
    • Institute of Marine Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention with cod 200 grams two times the week for four months.	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.
Experimental: Control group; Control group which will continue to eat their habitual diet.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Bayley Scale of Infant Developmental scores between groups	Student's t-test to compare the means between the groups.	17 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Institute of Nutrition and Seafood Research, Norway
• Collaborators: NORCE Norwegian Research Centre AS
• Investigators: Study Chair: Marian Kjellevold, PhD, Institute of Marine Research

Publications and helpful links

General Publications

• Naess S, Markhus MW, Strand TA, Kjellevold M, Dahl L, Stokland AM, Nedrebo BG, Aakre I. Iodine Nutrition and Iodine Supplement Initiation in Association with Thyroid Function in Mildly-to-Moderately Iodine-Deficient Pregnant and Postpartum Women. J Nutr. 2021 Oct 1;151(10):3187-3196. doi: 10.1093/jn/nxab224.
• Kvestad I, Hysing M, Kjellevold M, Naess S, Dahl L, Markhus MW. Maternal Cod Intake during Pregnancy and Infant Development in the First Year of Life: Secondary Analyses from a Randomized Controlled Trial. J Nutr. 2021 Jul 1;151(7):1879-1885. doi: 10.1093/jn/nxab083.
• Markhus MW, Hysing M, Midtbo LK, Nerhus I, Naess S, Aakre I, Kvestad I, Dahl L, Kjellevold M. Effects of Two Weekly Servings of Cod for 16 Weeks in Pregnancy on Maternal Iodine Status and Infant Neurodevelopment: Mommy's Food, a Randomized-Controlled Trial. Thyroid. 2021 Feb;31(2):288-298. doi: 10.1089/thy.2020.0115. Epub 2020 Sep 8.
• Naess S, Kjellevold M, Dahl L, Nerhus I, Midtbo LK, Bank MS, Rasinger JD, Markhus MW. Effects of seafood consumption on mercury exposure in Norwegian pregnant women: A randomized controlled trial. Environ Int. 2020 Aug;141:105759. doi: 10.1016/j.envint.2020.105759. Epub 2020 May 7.
• Naess S, Aakre I, Kjellevold M, Dahl L, Nerhus I, Midtbo LK, Markhus MW. Validation and reproducibility of a new iodine specific food frequency questionnaire for assessing iodine intake in Norwegian pregnant women. Nutr J. 2019 Oct 29;18(1):62. doi: 10.1186/s12937-019-0489-4.
• Markhus MW, Kvestad I, Midtbo LK, Nerhus I, Odegaard ER, Graff IE, Lie O, Dahl L, Hysing M, Kjellevold M. Effects of cod intake in pregnancy on iodine nutrition and infant development: study protocol for Mommy's Food - a randomized controlled trial. BMC Nutr. 2018 Feb 17;4:7. doi: 10.1186/s40795-018-0215-1. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 17, 2018

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2015/879