UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052350 |
|---|---|
| Receipt number | R000059740 |
| Scientific Title | Clinical study of vitamin D supplementation for breast-fed infants. |
| Date of disclosure of the study information | 2023/09/29 |
| Last modified on | 2023/09/29 11:59:42 |
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Basic information
Public title
Clinical study of vitamin D supplementation for breast-fed infants.
Acronym
Clinical study of vitamin D supplementation for breast-fed infants.
Scientific Title
Clinical study of vitamin D supplementation for breast-fed infants.
Scientific Title:Acronym
Clinical study of vitamin D supplementation for breast-fed infants.
Region
| Japan |
Condition
Condition
Breast-fed infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Weekly vitamin D administration to infants from early postnatal period can prevent vitamin D insufficiency (25(OH)D < 20 ng/mL) without adverse events.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of vitamin D insufficiency (25(OH)D < 20 ng/mL) after weekly Vitamin D supplementation for three months.
Key secondary outcomes
Comparison of following items between intervention and historical control group.
1. Serum concentration of 25(OH)D after vitamin D supplementation.
2. Serum concentration of markers for bone metabolism (Ca, P, ALP, intact PTH etc).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Weekly vitamin D supplementation (1000-1400 IU/dose) for three months.
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
| 1 | days-old | <= |
Age-upper limit
| 3 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Breast-fed or mixed-fed healthy infants born after 36 weeks of gestation.
Key exclusion criteria
Infants with chromosomal abnormalities or multiple congenital malformations.
Infants with feeding problems or failure to thrive.
Infants born before 36 weeks of gestation.
Target sample size
111
Research contact person
Name of lead principal investigator
| 1st name | Kazushige |
| Middle name | |
| Last name | Ikeda |
Organization
Saitama city hospital
Division name
Division of Neonatology, Department of Pediatrics
Zip code
336-8522
Address
2460 Mimuro, Midori-ku, Saitama-city, Saitama, Japan
TEL
+81-48-873-4111
kazuiked@keio.jp
Public contact
Name of contact person
| 1st name | Kazushige |
| Middle name | |
| Last name | Ikeda |
Organization
Saitama city hospital
Division name
Division of Neonatology, Department of Pediatrics
Zip code
336-8522
Address
2460 Mimuro, Midori-ku, Saitama-city, Saitama, Japan
TEL
+81-48-873-4111
Homepage URL
kazuiked@keio.jp
Sponsor or person
Institute
Saitama city hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Perinatal and Neonatal Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio university hospital.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Saitama City Hospital
Address
2460 Mimuro, Midori-ku, Saitama-city, Saitama, Japan
Tel
+81-48-873-4111
hsp-jimukyoku-somu@city.saitama.lg.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
さいたま市立病院（埼玉県）、慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059740
