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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030654
Receipt No. R000034998
Scientific Title Breastfeeding and maternal nutrition in relation to offspring IQ at age 5. Findings from the lifestyle during pregnancy study.
Date of disclosure of the study information 2017/12/31
Last modified on 2017/12/31

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Basic information
Public title Breastfeeding and maternal nutrition in relation to offspring IQ at age 5. Findings from the lifestyle during pregnancy study.
Acronym Early nutrition and IQ at age 5 in the lifestyle during pregnancy study.
Scientific Title Breastfeeding and maternal nutrition in relation to offspring IQ at age 5. Findings from the lifestyle during pregnancy study.
Scientific Title:Acronym 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
1st name
Middle name
Last name Sjurdur Frodi Olsen
Organization Statens Serum Institut
Division name Maternal Nutrition Group
Zip code
Address Artillerivej 5
TEL 32683955
Email sfo@ssi.dk

Public contact
Name of contact person
1st name
Middle name
Last name Marin Stroem
Organization Statens Serum Institut
Division name Maternal Nutrition Group
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2003 Year 09 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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