UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039708 |
|---|---|
| Receipt number | R000045287 |
| Scientific Title | Study for the effects of molecular hydrogen on the cytokine and oxidative stress levels in pregnant women |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/05 12:31:16 |
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Basic information
Public title
Study for the effects of molecular hydrogen on the cytokine and oxidative stress levels in pregnant women
Acronym
Effects of molecular hydrogen on pregnancy
Scientific Title
Study for the effects of molecular hydrogen on the cytokine and oxidative stress levels in pregnant women
Scientific Title:Acronym
Effects of molecular hydrogen on pregnancy
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship of maternal molecular hydrogen intake to cytokines and oxidative stress
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship of maternal molecular hydrogen intake to cytokines and oxidative stress, especially pro-inflammatory cytokines and 8OHdG
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the relationship of molecular hydrogen intake to cytokines and oxidative stress in pregnant women
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest a hydrogen-containing beverage that is licensed and commercial available as a health food. The intake should be 200-300mL / time x 1-3 times / day in principle. Therefore, the longest intake period is about 24 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
All pregnant women over than or equal to 16 gestational-age and minimum age of 20 years
Key exclusion criteria
Pregnant women, considered unsuitable for participation in this study by the investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Imai |
Organization
Nagoya University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
kenchan2@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Imai |
Organization
Nagoya University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
Homepage URL
kenchan2@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-744-2479
iga-shinsa@adm.nagoya-u.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
| 2020 | Year | 04 | Month | 01 | 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
| 2020 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2020 | Year | 03 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045287
