DietMommy'sFoodNCT02610959
Iodine Status During Pregnancy and Its Effect on Infant Development.
A study testing Intervention group in people with Diet and Neurodevelopment, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet, Neurodevelopment
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2015to 17 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ≤ 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.
Who cannot join
- allergies to fish,
- chronic diseases known to affect iodine status (Graves' disease, Thyroiditis, Thyroid Nodules, known hypothyroidism, known hyperthyroidism).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet, Neurodevelopment
- Being tested
- Intervention group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention with cod 200 grams two times the week for four months. Receives: Other: Intervention group |
| Control group | Experimental | Control group which will continue to eat their habitual diet. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (1)
Difference in Bayley Scale of Infant Developmental scores between groups
Student's t-test to compare the means between the groups.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion1 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nutrition and Seafood Research, Norway
- Sponsor type
- Other government
- Collaborators
- NORCE Norwegian Research Centre AS
- Responsible party
- Principal investigator, Marian Kjellevold, National Institute of Nutrition and Seafood Research, Norway
- Investigators
- Marian Kjellevold, PhD, Study chair, Institute of Marine Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610959
- Sponsor's protocol ID
- 2015/879
- Acronym
- Mommy'sFood
- Status last verified
- Apr 2023
- First submitted
- 17 Nov 2015
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37858724Naess 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.
PubMed 34255063Kvestad 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.
PubMed 33847344Markhus 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.
PubMed 32746774Naess 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.
PubMed 32388274Markhus 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.
PubMed 32153871Naess 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.
PubMed 31665021
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Status During Pregnancy and Its Effect on Infant Development; a Randomized Intervention Study With Cod
- ClinicalTrials.gov ID
- NCT02610959
- Acronym / sponsor ID
- Mommy'sFood / 2015/879
- Conditions
- Diet, Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- National Institute of Nutrition and Seafood Research, NorwayOther government
- Collaborators
- NORCE Norwegian Research Centre AS
- Study start
- Dec 2015
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupIntervention with cod 200 grams two times the week for four months. |
| Control group | Experimental | Other: Control groupControl group which will continue to eat their habitual diet. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- ≤ 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.
Key exclusion criteria (2 listed)
- allergies to fish,
- chronic diseases known to affect iodine status (Graves' disease, Thyroiditis, Thyroid Nodules, known hypothyroidism, known hyperthyroidism).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupThe overall aim of the present project is to investigate if intake of cod in pregnancy has impact on infant development up to 12 month. | Other | Intervention group |
| Control groupThe overall aim of the present project is to investigate if intake of cod in pregnancy has impact on infant development up to 12 month. | Other | Control group |
Primary outcome
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.
1 secondary outcome
Difference in Bayley Scale of Infant Developmental scores between groups
Time frame: 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 37858724G 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.
- Derived from this study: PubMed 34255063Naess 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.
- Derived from this study: PubMed 33847344Kvestad 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.
- Derived from this study: PubMed 32746774Markhus 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.
- Derived from this study: PubMed 32388274Naess 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.
- Derived from this study: PubMed 32153871Markhus 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.
- Derived from this study: PubMed 31665021Naess 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marian Kjellevold, PhD study chair
Institute of Marine Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Diet and Neurodevelopment, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Urinary iodine concentration between groups (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610959, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.