UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054184 |
|---|---|
| Receipt number | R000061871 |
| Scientific Title | Study of formula milk with breast milk-derived new ingredient (nicotinamide mononucleotide) on energy metabolism of baby: multicenter, double-blinded, randomized, commercial product-controlled trial |
| Date of disclosure of the study information | 2024/04/18 |
| Last modified on | 2024/04/18 11:46:45 |
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Basic information
Public title
Study of formula milk with breast milk-derived new ingredient (nicotinamide mononucleotide) on energy metabolism of baby: multicenter, double-blinded, randomized, commercial product-controlled trial
Acronym
SMILE-Baby study
Scientific Title
Study of formula milk with breast milk-derived new ingredient (nicotinamide mononucleotide) on energy metabolism of baby: multicenter, double-blinded, randomized, commercial product-controlled trial
Scientific Title:Acronym
SMILE-Baby study
Region
| Japan |
Condition
Condition
Healthy infant
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate exploratorily the effect of NMD-containing infant milk fomula on blood NAD levels of infant by targeting artificially or mixed-fed infants and their mothers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood NAD concentration
Key secondary outcomes
1. NMN metabolite in blood or urine of infants
2. Blood biochemical laboratory test values of infants
3. Body measurements (hight, weight, etc.)
4. Frequeycy of adverse events in infants that is considered to be related with the consumption of the study milk
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Study infant milk fomula group
- consume study infant milk fomula containing NMN (nutritional composition other than NMN is identical to commercial infant milk fomula) for 4 weeks after discharge from hospital
Interventions/Control_2
Control infant milk fomula group
- consume control infant milk fomula without NMN (commercial infant milk fomula) for 4 weeks after discharge from hospital
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Infants who are born between 28 and 37 weeks of gestation and their mothers aged of 18 years or older
2. Infants who are hospitalized but healthy and expected to have a normal life after discharge from hospital, and their mother
3. Mixed or artificially-fed infants and their mothers
4. Infants for whom the nutritional composition of infant milk fomula is suitable as a supplement to insufficient breast milk, and their mother
5. Infants whose mother and regal representatives (persons with parental authority) give the consent to participate in this study in written form after full explanation and full understanding of this study, and their mother theirselves
Key exclusion criteria
1. Infants with serious infection and their mothers
2. Infants with serious diseases and their mothers
3. Infants with other conditions that the responsible investigator or subinvestigators judge inappropriate to participate in this study
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Shoji |
Organization
Juntendo University Hospital
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
hshoji@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Arata |
| Middle name | |
| Last name | Yoneda |
Organization
EviPRO Co., Ltd.
Division name
Clinical Study Support Division
Zip code
101-0032
Address
KDX Iwamoto-cho Building 2F, Iwamoto-cho 3-11-9, Chiyoda, Tokyo
TEL
03-5829-4110
Homepage URL
yoneda_arata@evipro.co.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 18 | 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
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
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061871
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
