UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030654 |
|---|---|
| Receipt number | 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 22:56:03 |
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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
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
mrm@ssi.dk
Sponsor or person
Institute
Maternal Nutrition Group, Statens Serum Institut
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034998
