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.
Not Applicable
- Conditions
- Chronic kidney disease (CKD)
- Registration Number
- JPRN-UMIN000002776
- Lead Sponsor
- Department of Nephrology, Kariya-Toyota General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.