UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002776 |
|---|---|
| Receipt number | R000003378 |
| Scientific Title | Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum asymmetric dimethylarginine (ADMA) concentration in patients receiving long-term hemodialysis. |
| Date of disclosure of the study information | 2009/11/17 |
| Last modified on | 2009/11/17 21:24:02 |
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Basic information
Public title
Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum asymmetric dimethylarginine (ADMA) concentration in patients receiving long-term hemodialysis.
Acronym
Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum ADMA concentration.
Scientific Title
Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum asymmetric dimethylarginine (ADMA) concentration in patients receiving long-term hemodialysis.
Scientific Title:Acronym
Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum ADMA concentration.
Region
| Japan |
Condition
Condition
Chronic kidney disease (CKD)
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of the current study is to investigate whether, in patients receiving long-term hemodialysis, combined administration of oral folate and intravenous methylcobalamin is more beneficial than oral folate alone at reducing the circulating level of ADMA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Our primary endpoint was the effect of co-administration of intravenous methylcobalamin and oral folate versus that of oral folate alone as regards normalization of plasma homocysteine (<15 micro mol/L) and reduction of serum ADMA in hemodialysis patients.
Key secondary outcomes
Secondary outcomes were the changes in the augmentation index and in the ratios of S-adenosylmethionine (SAM) to S-adenosylhomocysteine (SAH) as a transmethylation indicator and dimethylamine (DMA) to ADMA and dimethylamine to ADMA as an ADMA-hydrolysis indicator.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients who received supplementation with folate alone (15 mg/day) for 3 weeks.
Interventions/Control_2
Patients who received supplementation with oral folate (15 mg/day) together with intravenous methylcobalamin (500 micro g after each hemodialysis session, 3 times/week) for 3 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with established end-stage renal disease undergoing maintenance hemodialysis in Kariya-Toyota General Hospital.
Key exclusion criteria
Exclusion criteria for this study were as follows: (1) severe anemia (hematocrit <25%), (2) diabetes mellitus, (3) evident infectious or inflammatory diseases, (4) malignant diseases, (5) homocystinuria, (6) smoking habit, (7) atherosclerosis obliterans, (8) left ventricular systolic dysfunction (ejection fraction <50%), (9) liver dysfunction, (10) specific indication for, or contraindication to, the study-drugs or study-procedures, (11) malnutrition [i.e., patients exhibiting subjective global nutritional assessment (SGA) score B or C] during the study period.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsushi Koyama |
Organization
Kariya-Toyota General Hospital
Division name
Department of Nephrology
Zip code
Address
5-15 Sumiyoshi-cho, Kariya 448-8505, Japan
TEL
+81-566-21-2450
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsushi Koyama |
Organization
Kariya-Toyota General Hospital
Division name
Department of Nephrology
Zip code
Address
5-15 Sumiyoshi-cho, Kariya 448-8505, Japan
TEL
+81-566-21-2450
Homepage URL
nephkidedta@do9.enjoy.ne.jp
Sponsor or person
Institute
Department of Nephrology, Kariya-Toyota General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pharmacology, Department of Cardio-Renal Medicine and Hypertension, Graduate School of Medical Sciences, Nagoya City University
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
刈谷豊田総合病院 (愛知県)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 17 | 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
Completed
Date of protocol fixation
| 2004 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 17 | Day |
Last modified on
| 2009 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003378
