Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004495
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
Sponsor:
Georgetown University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Compare the efficacy of two doses of folic acid in normalizing plasma total homocysteine concentration in patients with end stage renal disease receiving regular hemodialysis therapy resulting in hyperhomocysteinemia
II Determine the requirement of co-supplementation with extra pyridoxine vitamin B6 and cyanocobalamin vitamin B12 daily in these patients
III Assess the safety and tolerability of this therapy in these patients
II Determine the requirement of co-supplementation with extra pyridoxine vitamin B6 and cyanocobalamin vitamin B12 daily in these patients
III Assess the safety and tolerability of this therapy in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized placebo controlled study Patients are stratified according to prestudy homocysteine levels above or below average Patients are randomized to receive placebo or one of two doses of oral folic acid with or without pyridoxine and cyanocobalamin
Arm I Patients receive oral placebo daily Arm II Patients receive oral pyridoxine cyanocobalamin and oral placebo daily
Arm III Patients receive oral pyridoxine cyanocobalamin and folic acid daily
Arm IV Patients receive oral pyridoxine and cyanocobalamin plus a higher dose of folic acid daily
Arm V Patients receive oral placebo and oral folic acid daily Arm VI Patients receive oral placebo and higher dose folic acid daily Treatment continues for 8 weeks
Completion date provided represents the completion date of the grant per OOPD records
Arm I Patients receive oral placebo daily Arm II Patients receive oral pyridoxine cyanocobalamin and oral placebo daily
Arm III Patients receive oral pyridoxine cyanocobalamin and folic acid daily
Arm IV Patients receive oral pyridoxine and cyanocobalamin plus a higher dose of folic acid daily
Arm V Patients receive oral placebo and oral folic acid daily Arm VI Patients receive oral placebo and higher dose folic acid daily Treatment continues for 8 weeks
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GUMC-FDR001544 | None | None | None |