UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027358 |
|---|---|
| Receipt number | 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 15:01:30 |
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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
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
kubame93@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031351
