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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027358
Receipt No. R000031351
Scientific Title Single arm and open-label study evaluating the effect of fucoidan intake on proviral load in carriers with human T-cell leukemia virus type-I
Date of disclosure of the study information 2017/05/17
Last modified on 2017/11/16

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Basic information
Public title Single arm and open-label study evaluating the effect of fucoidan intake on proviral load in carriers with human T-cell leukemia virus type-I
Acronym Effect of fucoidan on proviral load in carriers with HTLV-1
Scientific Title Single arm and open-label study evaluating the effect of fucoidan intake on proviral load in carriers with human T-cell leukemia virus type-I
Scientific Title:Acronym Effect of fucoidan on proviral load in carriers with HTLV-1
Region
Japan

Condition
Condition Human T-cell leukemia virus type-I (HTLV-1) infection
Classification by specialty
Hematology and clinical oncology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of fucoidan on proviral load in HTLV-1 carriers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HTLV-1 proviral load (real-time PCR method)
Key secondary outcomes fucoidan concentration in urine (ELISA), Immune function (flow cytometric analysis of cell surface marker)

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 Fucoidan-drink (fucoidan 1 g/50 ml/bottle, 3 bottles/day)for 6 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Those who are diagnosed as HTLV-1 carrier in Kariyushi-Hospital on Ishigaki Island, Okinawa, Japan
2. Aged 20 years or older
3. HTLV-1 proviral load >= 4 copies/100 peripheral mononuclear cells
4. Available to participate within the study time frame
5. Consent to participate for the study
Key exclusion criteria 1. Those who have developed HTLV-1 associated diseases (ATL, HAM/TSP, HU)
2. Those who suffered any other malignant tumor and receive medical treatment
3. Those who suffer from systemic infection
4. Those who receive medical treatment that might affect HTLV-1 proviral load
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Fukushima
Organization University of the Ryukyus
Division name Laboratory of Hematoimmunology, School of Health Sciences, Faculty of Medicine
Zip code
Address 207 Uehara, Nishihara, Okinawa, Japan
TEL +81-98-895-1276
Email fukutaku@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Megumi Kuba-Miyara
Organization University of the Ryukyus
Division name Laboratory of Hematoimmunology, School of Health Sciences, Faculty of Medicine
Zip code
Address 207 Uehara, Nishihara, Okinawa, Japan
TEL +81-98-895-3331(ext.2652)
Homepage URL
Email kubame93@med.u-ryukyu.ac.jp

Sponsor
Institute University of the Ryukyus
Institute
Department

Funding Source
Organization Department of Agriculture, Forestry and Fisheries, Okinawa Prefectural Government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor South Product Co., Ltd, Kariyushi Hospital, Jozen-kai Medical Corporation (Ishigaki Island, Okinawa)
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 医療法人上善会かりゆし病院(沖縄県)、琉球大学医学部保健学科血液免疫検査学分野

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 16 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031351

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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