UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045164 |
|---|---|
| Receipt number | R000051467 |
| Scientific Title | Comprehensive evaluation of One Carbon Metabolism by folic acid supplementation in women with childbearing age |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2022/08/18 17:34:37 |
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Basic information
Public title
Comprehensive evaluation of One Carbon Metabolism by folic acid supplementation in women with childbearing age
Acronym
One Carbon Metabolism by folic acid supplementation
Scientific Title
Comprehensive evaluation of One Carbon Metabolism by folic acid supplementation in women with childbearing age
Scientific Title:Acronym
One Carbon Metabolism by folic acid supplementation
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluating how the one-carbon metabolism, which supplies methyl groups for DNA, changes, and whether unmetabolized folic acid increases when women of childbearing age with different genetic backgrounds take folic acid supplements (pteroyl monoglutamate).
Basic objectives2
Others
Basic objectives -Others
Evaluating how the one-carbon metabolism change by long term intake of puteroyl monoglutamate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-methyltetrahydrofolate
Key secondary outcomes
serine, glycine, vitamin B2, pyridoxine, pyridoxamine, methionine, homocysteine, choline, betaine, dimethylglycine, s-adenosylmethionine, s-adenosylhomocysteine, cystathionine, cysteine, taurine, unmetabolized folic acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
400mcg/day folic acid supplementation for 120 days
Interventions/Control_2
800mcg/day folic acid supplementation for 120 days
Interventions/Control_3
Placebo for 120 days
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Females between the ages of 18 and 25 years old at the time of obtaining consent to participate in this study
Key exclusion criteria
1) Suffering from or history of serious hepatic disorder, renal, cardiac, pulmonary, or gastrointestinal (including gastrectomy) disease, diabetes, food allergy, or other serious disease
2) Taking medications which are related to lipid and/or folate metabolism that may affect outcomes in this study.
3) Pregnant, lactating women, or planning to become pregnant.
4) Systolic blood pressure < 90 mmHg
5) Donated component blood or 200 mL of whole blood drawn for one month prior to the start of this study
6) 400 mL of whole blood drawn for 4 months prior to the start of this study
7) 800 mL of whole blood drawn for 12 months prior to the start of this study
8) Participating other clinical trials, or within 4 weeks of completion of the clinical trial
9) BMI of 30 or higher
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Terue |
| Middle name | |
| Last name | kawabata |
Organization
Kagawa Nutrition University
Division name
Basic Nutrition Laboratory
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado-shi Saitama-ken
TEL
049-282-3705
kawabata@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Shoji |
Organization
Kagawa Nutrition University
Division name
Basic Nutrition Laboratory
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado-shi Saitama-ken
TEL
049-282-3705
Homepage URL
shoji.kumiko@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sendai Shirayuri Women`s University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Nutrition University
Address
3-9-21 Chiyoda Sakado-shi Saitama-ken
Tel
049-282-3705
shoji.kumiko@eiyo.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
| 2021 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051467
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| Registered date | File name |
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