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

Email



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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name