UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030455 |
|---|---|
| Receipt number | R000034762 |
| Scientific Title | Effects of dietary iron restriction in patients with hypertension |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2017/12/18 19:02:18 |
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Basic information
Public title
Effects of dietary iron restriction in patients with hypertension
Acronym
Iron restriction and hypertension
Scientific Title
Effects of dietary iron restriction in patients with hypertension
Scientific Title:Acronym
Iron restriction and hypertension
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to clarify the antihypertensive and organ protective effect, and the safety of the dietary iron restriction of patients with hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure change at 3 months after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
dietary iron restriction
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. Patients with hypertension.
2. Patients who were judged to be able to participate in the study by the attending physician.
3. Patients who were able to acquire consent by themselves.
Key exclusion criteria
1. Patients who do not satisfy the adaptation criteria.
2. Patients with malignant tumor complications
3. Patients with anemia
4. Patients with iron deficiency
5. Patients who have suffered brain/cardiovascular disease such as myocardial infarction and stroke.
6. Patients who were judged to inappropriate for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Masuyama |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho Nishinomiya City Hyogo, Japan
TEL
0798-45-6553
masuyama@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Naito |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho Nishinomiya City Hyogo, Japan
TEL
0798-45-6553
Homepage URL
ynaito@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034762
