NCT02610959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

November 17, 2015

Last Update Submit

April 14, 2023

Conditions

DietNeurodevelopment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Difference in Bayley Scale of Infant Developmental scores between groups

    17 months

Other Outcomes (5)

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

    Infant age 3, 6 and 11 months

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

    Infant age 3, 6 and 11 months

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

    Child age five-six years

  • +2 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention with cod 200 grams two times the week for four months.

Other: Intervention group

Control group

EXPERIMENTAL

Control group which will continue to eat their habitual diet.

Other: Control group

Interventions

Intervention groupOTHER

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.

Intervention group
Control groupOTHER

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

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ≤ 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Marine Research

Bergen, 5817, Norway

Location

Related Publications (7)

  • G Bjorkevoll SM, Konijnenberg C, Kvestad I, McCann A, Ueland PM, Naess Sleire S, Dahl L, Kjellevold M, Strand TA, Markhus MW. Vitamin B12 and Folate Status in Pregnant Females and Their Infants in Norway: Secondary Analysis from the Mommy's Food Study. J Nutr. 2023 Dec;153(12):3543-3554. doi: 10.1016/j.tjnut.2023.10.013. Epub 2023 Oct 18.

    PMID: 37858724DERIVED

  • 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.

    PMID: 34255063DERIVED

  • 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.

    PMID: 33847344DERIVED

  • 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.

    PMID: 32746774DERIVED

  • 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.

    PMID: 32388274DERIVED

  • 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.

    PMID: 32153871DERIVED

  • 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.

    PMID: 31665021DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Marian Kjellevold, PhD

    Institute of Marine Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Scientist

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 17, 2018

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

NO(1)