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.

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. - Randomized, controlled trial of the effect of short-term co-administration of methylcobalamin and folate on serum ADMA concentration.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002776

Enrollment

Registered

2009-11-17

Start date

2004-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease (CKD)

Interventions

Patients who received supplementation with folate alone (15 mg/day) for 3 weeks. Patients who received supplementation with oral folate (15 mg/day) together with intravenous methylcobalamin (500 micr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with established end-stage renal disease undergoing maintenance hemodialysis in Kariya-Toyota General Hospital.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactKatsushi Koyama

Kariya-Toyota General Hospital Department of Nephrology

nephkidedta@do9.enjoy.ne.jp+81-566-21-2450

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026