UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034999 |
|---|---|
| Receipt number | R000039590 |
| Scientific Title | 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 | 2021/05/29 09:49:24 |
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Basic information
Public title
Studies on the associations between vitamin B1 and E status and cardiac indices in patients with heart failure
Acronym
Studies on vitamin B1 and E status in patients with heart failure
Scientific Title
Studies on the associations between vitamin B1 and E status and cardiac indices in patients with heart failure
Scientific Title:Acronym
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
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Kobe Gakuin University
Division name
Faculty of Nutrition
Zip code
651-2113
Address
518, Ikawadani-choarise, Nishi-ku, Kobe, Hyogo 651-2180, JAPAN
TEL
078-974-4998
ktanaka@nutr.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Kobe Gakuin University
Division name
Faculty of Nutrition
Zip code
652-2113
Address
518, Ikawadani-choarise, Nishi-ku, Kobe, Hyogo 651-2180, JAPAN
TEL
078-974-4998
Homepage URL
ktanaka@nutr.kobegakuin.ac.jp
Sponsor or person
Institute
Department of Cardiology, Federation of National Public Service Personnel Mutual Aid Associations Hirakatakohsai Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Federation of National Public Service Personnel Mutual Aid Associations Hirakatakohsai Hospital
Address
1-2-1 Fujisakahigashi-cho, Hirakata-shi, Osaka
Tel
072-858-8233
hirakoh@gmail.com
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 |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
85
Results
A logistic regression analysis adjusted for age, gender, BMI, triglycerides, malondialdehyde-modified LDL showed that the significant contributors to the risk of heart failure were lipid-corrected gamma-tocopherol concentration and estimated glomerular filtration rate (eGFR). These results suggest that subjects with higher serum gamma-tocopherol levels are at a lower risk of heart failure.
Results date posted
| 2021 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Outpatients without heart failure or myocardial infarction who have registered in Kitakawachi Clinical Background and Outcome of Heart Failure Registry
Participant flow
Data collection during normal outpatient care
Adverse events
No adverse events
Outcome measures
Main outcome measures: Circulating levels of vitamins (vitamin B1, B6, B12, folate, niacin, biotin, pantothenic acid, vitamin C, vitamin E)
Second outcome measures: Biomarkers of oxidative stress, indices for cardiac function such as an echocardiogram
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2021 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039590
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