UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	kenchan2@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045287