UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020409 |
|---|---|
| Receipt number | R000023557 |
| Scientific Title | Effect of nutritional vitamin D supplements in hemodialysis patients |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2017/03/10 10:50:41 |
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Basic information
Public title
Effect of nutritional vitamin D supplements in hemodialysis patients
Acronym
Nutritional vitamin D supplementation in hemodialysis patients
Scientific Title
Effect of nutritional vitamin D supplements in hemodialysis patients
Scientific Title:Acronym
Nutritional vitamin D supplementation in hemodialysis patients
Region
| Japan |
Condition
Condition
CKD-5D
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the serum 25(OH)D level in hemodialysis patients. Additionally, to assess the effects of supplementation in hemodialysis patients with nutritional vitamin D.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum 25(OH)D and 1,25(OH)2D levels at 6 and 12 months after the beginning of supplementation of nutritional vitamin D.
Key secondary outcomes
Serum calcium, phosphorus, albumin, and intact parathyroid hormone levels, CRP(C-reactive protein) levels, Serum fibroblast growth factor 23 (FGF 23)levels, hemoglobin (Hb) levels,
changes in blood pressure, medication use (erythrocyte-stimulating agents, activated vitamin D)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ingestion of ergocalciferol (vitamin D2, which comes from plant sources), 400 IU daily for 6 months of the first half, and continue to take it at the same dose for 6 months of the latter half.
Interventions/Control_2
Ingestion of ergocalciferol (vitamin D2, which comes from plant sources), 400 IU daily for 6 months of the first half, and continue to take it at the same dose, additionally oral cholecalciferol (vitamin D3, which comes from animal sources), 7000 IU weekly for 6 months of the latter half.
Interventions/Control_3
Control group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. hemodialysis patients
2. Subjects who agree to participate in the current study with a written informed consent
Key exclusion criteria
1. Subjects who are at risk of having allergic reactions to drugs or supplements
2. Subjects who regularly take
nutritional vitamin D
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Okamoto |
Organization
Saiseikai Wakayama Hospital
Division name
Kidney Center
Zip code
Address
12 banchou 45, Wakaya, Japan
TEL
073-424-5185
mokamoto@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Okamoto |
Organization
Saiseikai Wakayama Hospital
Division name
Kidney Center
Zip code
Address
12 banchou, Wakayama, Japan
TEL
073-424-5185
Homepage URL
mokamoto@wakayama-med.ac.jp
Sponsor or person
Institute
Saiseikai Wakayama Hospital
Institute
Department
Personal name
Funding Source
Organization
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Division of Nephrology, Wakayama Medical University, Japan
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
| 2015 | Year | 12 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | 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
| 2015 | Year | 12 | Month | 31 | Day |
Last modified on
| 2017 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023557
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
