UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000430
Receipt number R000000522
Scientific Title Vitamin C reversed migratory dysfunction of mononuclear cells in smokers
Date of disclosure of the study information 2006/08/01
Last modified on 2006/06/16 15:22:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Vitamin C reversed migratory dysfunction of mononuclear cells in smokers

Acronym

VICM

Scientific Title

Vitamin C reversed migratory dysfunction of mononuclear cells in smokers

Scientific Title:Acronym

VICM

Region

Japan


Condition

Condition

Healthy young male smokers who does not have coronary risk factors without smoking

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether vitamin C reversed the impaired migratory function of mononuclear cell in smokers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Migratory function of mononuclear cells

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

2 weeks administration of Vitamin C(3.0g/day, smokers)

Interventions/Control_2

Non-smokers does not take Vitamin C.

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

21 years-old <=

Age-upper limit

40 years-old >

Gender

Male

Key inclusion criteria

Healthy young smokers without coronary risk factor.

Key exclusion criteria

Patient with coronary risk factors.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Katsuki

Organization

Kurume University

Division name

Department of intarnal medicine division of cardio-vascular medicine

Zip code


Address

67-Asahi machi, Kurume, Fukuoka, Japan

TEL

0942-35-3311

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshio Katsuki

Organization

Kurume University

Division name

Department of intarnal medicine division of cardio-vascular medicine

Zip code


Address

67-Asahi machi, Kurume, Fukuoka, Japan

TEL

0942-35-3311

Homepage URL


Email

katsuki_yoshio@kurume-u.ac.jp


Sponsor or person

Institute

Kurume University, Department of intarnal medicine division of cardio-vascular medicine

Institute

Department

Personal name



Funding Source

Organization

Kurume University, Department of intarnal medicine division of cardio-vascular medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

No

Name of secondary funder(s)

No


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

2006 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Vitamin C reversed the smoking induced impaired migratory function of mononuclear cells

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

2005 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 08 Month 01 Day

Last follow-up date

2005 Year 11 Month 01 Day

Date of closure to data entry

2006 Year 11 Month 01 Day

Date trial data considered complete

2006 Year 11 Month 01 Day

Date analysis concluded

2006 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 06 Month 16 Day

Last modified on

2006 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000522


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name