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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034999
Receipt No. R000039590
Official scientific title of the study Studies on the associations between vitamin B1 and E status and cardiac indices in patients with heart failure
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/03

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Basic information
Official scientific title of the study Studies on the associations between vitamin B1 and E status and cardiac indices in patients with heart failure
Title of the study (Brief title) Studies on vitamin B1 and E status in patients with heart failure
Region
Japan

Condition
Condition Cardiovascular diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the association of vitamins status with cardiac indices in patients with heart failure
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Circulating levels of vitamins (vitamin B1, B6, B12, folate, niacin, biotin, pantothenic acid, vitamin C, vitamin E)
Key secondary outcomes Echocardiogram
Biomarkers of oxidative stress
Serum haptoglobin

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1 Outpatients without heart failure or myocardial infarction who have registered in Kitakawachi Clinical Background and Outcome of Heart Failure Registry

2 Having provided voluntary written consent for participation in this study
Key exclusion criteria 1. Patients who have already taken some vitamins supplementation

2. Over 90 years-old patients.

3. Patients with chronic kidney diseases (<eGFR 30mL/min/1.73m2)
Target sample size 100

Research contact person
Name of lead principal investigator Kiyoshi Tanaka
Organization Kobe Gakuin University
Division name Faculty of Nutrition
Address 518, Ikawadani-choarise, Nishi-ku, Kobe, Hyogo 651-2180, JAPAN
TEL 078-974-4998
Email ktanaka@nutr.kobegakuin.ac.jp

Public contact
Name of contact person Kiyoshi Tanaka
Organization Kobe Gakuin University
Division name Faculty of Nutrition
Address 518, Ikawadani-choarise, Nishi-ku, Kobe, Hyogo 651-2180, JAPAN
TEL 078-974-4998
Homepage URL
Email ktanaka@nutr.kobegakuin.ac.jp

Sponsor
Institute Department of Cardiology, Federation of National Public Service Personnel Mutual Aid Associations Hirakatakohsai Hospital
Institute
Department

Funding Source
Organization Kobe Gakuin University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor 1) Federation of National Public Service Personnel Mutual Aid Associations Hirakatakohsai Hospital
2) Department of Clinical Nutrition, Faculty of Comprehensive Rehabilitation, Osaka Prefecture University
3) Department of Food and Nutrition, Kyoto Women's University
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 国家公務員共済組合連合会 枚方公済病院(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 15 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Observational study

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039590

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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