UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023110
Receipt No. R000026594
Scientific Title Follow-up Investigation on Infant Growth and Nutritional Intake
Date of disclosure of the study information 2017/12/31
Last modified on 2020/01/14 (Ver. 4)

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Basic information
Public title Follow-up Investigation on Infant Growth and Nutritional Intake
Acronym Follow-up Investigation on Infant Growth and Nutritional Intake
Scientific Title Follow-up Investigation on Infant Growth and Nutritional Intake
Scientific Title:Acronym Follow-up Investigation on Infant Growth and Nutritional Intake
Region
Japan

Condition
Condition Formula-fed infant
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the growth of breast-fed and formula-fed infants.
To obtain the factual data on feeding amount and pattern.
Basic objectives2 Others
Basic objectives -Others Substantial investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body weight
Key secondary outcomes Formula intake per day
Body length
Head circumference
Stool characteristics (number, colour, form)
Formula intake per feeding
Number of feeding per day
Number of weaning foods
Others


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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Infant at 1 month of age
2. Infant feeding brestmilk or Hohoemi-formula
3. Subjects whose guardian gave written informed consent
Key exclusion criteria Subjects who are judged as unsuitable for the study by the investigator.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Nakamura
Organization Meiji Co., Ltd.
Division name Food Science Research Laboratories, R&D Division
Zip code
Address 540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL 0465-37-3661
Email yoshitaka.nakamura@meiji.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Jinno
Organization Meiji Co., Ltd.
Division name Food Science Research Laboratories, R&D Division
Zip code
Address 540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL 0465-37-3661
Homepage URL
Email shinji.jinno@meiji.com

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

Funding Source
Organization Meiji Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 31 Day

Related information
URL releasing protocol https://www.tandfonline.com/doi/full/10.1080/09168451.2019.1689096
Publication of results Published

Result
URL related to results and publications https://www.tandfonline.com/doi/full/10.1080/09168451.2019.1689096
Number of participants that the trial has enrolled 1053
Results 
In this observational study, 1,053 infants were followed-up to 12 months. Body weight, body mass index, and head circumference of Formula A-fed infants were similar to those of breastfed infants. Additionally, there were no differences in the stool consistency and the health condition (infection and allergy prevalence) between the two groups. Formula A-fed infants grew as well as breastfed infants, suggesting the appropriate nutritional composition of Formula A.
Results date posted
2020 Year 01 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
There are no difference in gestational age, rate of cesarean section, weight, body mass index, and head circumference at birth between Formula-Fed and breastfed boy infants. In girls, there were significant differences only in rate of cesarean section and birth weight between Formula A-fed and breast-fed girl infants.
Participant flow 
We obtained informed consent from 1,053 participants. Finally, 394 (295 breastfed, 99 Formula A-fed) infants were included.
Adverse events 
Not applicable
Outcome measures 
Body weight, Body mass index, head circumference, stool consistency and Health condition
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 08 Month 25 Day
Date of IRB
2014 Year 08 Month 25 Day
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Relation between the mode of feeding and the infant growth
Prospective study
Case-control study

Management information
Registered date
2016 Year 07 Month 11 Day
Last modified on
2020 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026594