UMIN-CTR Clinical Trial

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

Intelligence in children at age 5 years

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Maternal Nutrition Group, Statens Serum Institut

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2017

Year

12

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

12

Month

31

Day

Last modified on

2017

Year

12

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034998