UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002473 |
|---|---|
| Receipt number | R000002399 |
| Scientific Title | Study of nutritional supports for reduction of complications in low birth weight infants-examination bathed from lipoprotein metabolism and body composition analysis from birth to 12 months of ages- |
| Date of disclosure of the study information | 2009/09/09 |
| Last modified on | 2016/03/09 11:03:47 |
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Basic information
Public title
Study of nutritional supports for reduction of complications in low birth weight infants-examination bathed from lipoprotein metabolism and body composition analysis from birth to 12 months of ages-
Acronym
Study of nutritional support for low birth weight infants
Scientific Title
Study of nutritional supports for reduction of complications in low birth weight infants-examination bathed from lipoprotein metabolism and body composition analysis from birth to 12 months of ages-
Scientific Title:Acronym
Study of nutritional support for low birth weight infants
Region
| Japan |
Condition
Condition
low birthweight infant, premature infant, normal birthweight infant
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Nutritional support for low birthweight infants for prevention of cardiovascular disease in future due to epigenetic effects.
Basic objectives2
Others
Basic objectives -Others
To know the relationship between de novo lipogenesis and epigenetic effects in low birthweight infants
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To know the mechanism of modified de novo lipogenesis in low birth weight infants due to epigenetic effects.
Key secondary outcomes
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
| 0 | months-old | <= |
Age-upper limit
| 12 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
gestational age
birth weight
RDS
Key exclusion criteria
infectious disease
congenital defects
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoo Okada |
Organization
Nihon university school of medicine
Division name
Department of Pediatrics and Child Health
Zip code
Address
30-1 Oyaguchi kamicho, Itabasiku, Tokyo 173-8610, Japan
TEL
0339728111
okada.tomoo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Okada |
Organization
Department of Pediatrics and Child Health
Division name
Department of Pediatrics and Child Health
Zip code
Address
30-1 Oyaguchi kamicho, Itabasiku, Tokyo 173-8610, Japan
TEL
0339728111
Homepage URL
okada.tomoo@nihon-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics and Child Health, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics and Child Health, Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nihon University School of Medicne, Itabashi Hospital
Name of secondary funder(s)
Department of Pediatrics and Child Health, Nihon University School of Medicine
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学板橋病院小児科
Nihon University Itabashi Hospital、Division of Pediatrics
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We could obtain the results that the body fatness predominantly has been caught up compared to the body weight in light for date infants within one month after birth. We found that the role of this mechanism may depend on not only IGF-1 but also LPL, which is the first report as far as we know.
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
Open public recruiting
Date of protocol fixation
| 2007 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
1) VLDL TG levels in cord blood were shown drastically increasing over than 32 gestational weeks, on the other hand, of which levels were low in infants who accompanied with RDS.
2) LFD infants who was borne over than 37 gestational weeks, whose total skinfold thickness caught up those of AFD in 30 days after birth, but not in body weight.
3) 600 days after impregnation, some LFD infants showed to become heavier and thicker skinfold compared to those of AFD.
Management information
Registered date
| 2009 | Year | 09 | Month | 09 | Day |
Last modified on
| 2016 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002399
| Research Plan | |
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