UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Breastfeeding and maternal nutrition in relation to offspring IQ at age 5. Findings from the lifestyle during pregnancy study.
Title of the study (Brief title)	Early nutrition and IQ at age 5 in the lifestyle during pregnancy study.
Region	Europe

Condition
Condition	Intelligence in children at age 5 years
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine, in an observational setting, the influence of breastfeeding and maternal nutrition on child IQ at 5 years of age.
Basic objectives2	Others
Basic objectives -Others	To take maternal IQ and home environment into account in analyses of the influence of breastfeeding and maternal nutrition on child IQ at age 5 years.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Child IQ assessed at age 5 years by the Wechsler Primary and Preschool Scales of Intelligence-Revised
Key secondary outcomes	Other neurodevelopmental outcomes assessed at the examination at age 5 in the LIfestyle during pregnancy study

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	5 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	The Lifestyle during pregnancy study (LDPS) consists of 3478 mother-child dyads selected from the DNBC with oversampling of pregnant women with moderate weekly alcohol intake, alcohol binge drinkers and women with high vs. low fish intake, iron intake and duration of breastfeeding, respectively. Of the selected dyads 1782 mothers and children (51%) took part.
Key exclusion criteria	Exclusion criteria for the follow-up in the Lifestyle during pregnancy study (LDPS) were multiple pregnancies, inability to speak Danish, impaired hearing or vision of the child likely to compromise the ability to perform the cognitive tests, and congenital disorders likely to cause mental retardation, including trisomy 21.
Target sample size	1782

Research contact person
Name of lead principal investigator	Sjurdur Frodi Olsen
Organization	Statens Serum Institut
Division name	Maternal Nutrition Group
Address	Artillerivej 5
TEL	32683955
Email	sfo@ssi.dk

Public contact
Name of contact person	Marin Stroem
Organization	Statens Serum Institut
Division name	Maternal Nutrition Group
Address	Artillerivej 5
TEL	32683960
Homepage URL
Email	mrm@ssi.dk

Sponsor
Institute	Maternal Nutrition Group, Statens Serum Institut
Institute
Department

Funding Source
Organization	The Danish National Board of Health, the Lundbeck Foundation, Elsass Foundation, Danielsens Foundation, European Union (FOOD-CT-2005-007036)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Denmark, European Union

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	pseudonymized pin
Org. issuing International ID_1	University of Aarhus
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2003 Year 09 Month 01 Day
Anticipated trial start date	2003 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We will investigate associations between maternal nutrition and breastfeeding on the one hand and child IQ at age 5 years on the other hand, while taking into account maternal IQ and home environment.
Other related information	Prospective study. We used data from The Lifestyle During Pregnancy Study, which consists of 1782 mother-child pairs sampled from the prospective Danish National Birth Cohort (n=101,042) based on maternal alcohol intake, diet and breastfeeding. The Danish National Birth Cohort is a population wide study.

Management information
Registered date	2017 Year 12 Month 31 Day
Last modified on	2017 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034998