UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020921
Receipt number R000024137
Scientific Title The effect of B vitamins on dyslipidemia of alcohol drinkers
Date of disclosure of the study information 2016/03/15
Last modified on 2016/02/07 22:49:17

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Basic information

Public title

The effect of B vitamins on dyslipidemia of alcohol drinkers

Acronym

alcohol-induced dyslipidemia and B vitamins

Scientific Title

The effect of B vitamins on dyslipidemia of alcohol drinkers

Scientific Title:Acronym

alcohol-induced dyslipidemia and B vitamins

Region

Japan


Condition

Condition

dyslipidemia

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine LDL, HDL, and TG for habitual alcohol-drinkers after administration of B vitamins

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

LDL,HDL,TG

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

administration of vitamin B6(20mg/d), vitaminB12 (0.5mg/d) and folic acid (0.8mg/d)

Interventions/Control_2

Placebo

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

30 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

habitual alcohol-drinkers


Key exclusion criteria

persons who take drugs for dyslipidemia

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaechang Park

Organization

Kochi health Check-ups Clinic

Division name

Brain Ckeck-ups Center

Zip code


Address

2-4-36 Chiyori-cho Kochi city Kochi prefecture

TEL

088-883-9711

Email

park@kenshin.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaechang Park

Organization

Kochi Health Check-ups Clinic

Division name

Brain Ckeck-ups Center

Zip code


Address

2-4-36 Chiyori-cho Kochi city Kochi prefecture

TEL

088-883-9711

Homepage URL


Email

park@kenchin.or.jp


Sponsor or person

Institute

Kochi University of Technology

Institute

Department

Personal name



Funding Source

Organization

Industrial Technology Center, Kochi prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 15 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

No longer recruiting

Date of protocol fixation

2015 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 07 Day

Last modified on

2016 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024137


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name