UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Takuya Fukushima
Organization	University of the Ryukyus
Division name	Laboratory of Hematoimmunology, School of Health Sciences, Faculty of Medicine
Address	207 Uehara, Nishihara, Okinawa, Japan
TEL	+81-98-895-1276
Email	fukutaku@med.u-ryukyu.ac.jp

Public contact
Name of contact person	Megumi Kuba-Miyara
Organization	University of the Ryukyus
Division name	Laboratory of Hematoimmunology, School of Health Sciences, Faculty of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031351