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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02331667
Date of registration:	17/12/2014
Prospective Registration:	No
Primary sponsor:	National Institute of Nutrition and Seafood Research, Norway
Public title:	The Effect of Diet on Learning Abilities for Children in Kindergarden
Scientific title:	The Effect of Diet on Learning Abilities for Children in Kindergarden
Date of first enrolment:	December 2014
Target sample size:	233
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02331667
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Norway

Contacts

Name:	Ingvild Eide Graff, PhD
Address:
Telephone:
Email:
Affiliation:	NIFES, Postboks 2029 Nordnes, 5817 Bergen, Norway

Key inclusion & exclusion criteria

Inclusion Criteria:

- Being 4-6 years old.

- Sufficient command of the Norwegian language of child to participate in cognitive
testing and of child and parents to comply with study requirements according to
investigators estimation.

Exclusion Criteria:

- Known food allergies

Age minimum: 4 Years
Age maximum: 6 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cognitive Performance

Intervention(s)

Other: Seafood

Other: Non-seafood

Primary Outcome(s)

WPSSI-III and Nine Hole peg test. [Time Frame: 5 months]

Secondary Outcome(s)

25-hydroxyvitamin D [Time Frame: 5 months]

Iodine concentration [Time Frame: 5 months]

Creatinine [Time Frame: 5 months]

Cholline pathway [Time Frame: 5 months]

Fatty acids [Time Frame: 5 months]

Ferritin [Time Frame: 5 months]

Inflammation [Time Frame: 5 months]

Sleep [Time Frame: 5 months]

Tryptophan pathway [Time Frame: 5 months]

Mental health [Time Frame: 5 months]

Mercury [Time Frame: 5 months]

Amino acids [Time Frame: 5 months]

B-vitamines [Time Frame: 5 months]

Secondary ID(s)

2014/1396

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NORCE Norwegian Research Centre AS

Ludwig-Maximilians - University of Munich

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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