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

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ClinicalTrials.gov Identifier: NCT02610959
Recruitment Status : Unknown
Verified May 2017 by Marian Kjellevold, National Institute of Nutrition and Seafood Research, Norway.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
NORCE Norwegian Research Centre AS
Information provided by (Responsible Party):
Marian Kjellevold, National Institute of Nutrition and Seafood Research, Norway

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.

Condition or disease Intervention/treatment Phase
Diet Neurodevelopment Other: Intervention group Other: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Iodine Status During Pregnancy and Its Effect on Infant Development; a Randomized Intervention Study With Cod
Study Start Date : December 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Difference in Bayley Scale of Infant Developmental scores between groups [ Time Frame: 17 months ]
    Groups will be compared in relation to delta-values before and after intervention/no intervention.



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610959


Locations
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Norway
NIFES
Bergen, Norway, 5817
Sponsors and Collaborators
National Institute of Nutrition and Seafood Research, Norway
NORCE Norwegian Research Centre AS
Investigators
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Study Chair: Marian Kjellevold, PhD NIFES

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Responsible Party: Marian Kjellevold, PhD, Scientist, National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier: NCT02610959     History of Changes
Other Study ID Numbers: 2015/879
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017