Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031057
Status:
COMPLETED
Last Update Posted:
2011-02-28
First Post:
2002-02-20
Brief Title:
Vitamin B Therapy for Hyperlactatemia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of Oral B Vitamin Therapy for Asymptomatic or Mildly Symptomatic Hyperlactatemia in Patients on NRTIs
Status:
COMPLETED
Status Verified Date:
2004-11
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:
The purpose of this study is to see if vitamin B can treat mild hyperlactatemia a higher than normal level of lactate in the blood in patients who take nucleoside reverse transcriptase inhibitors NRTIs
Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI therapy A lack of vitamin B may be related to the development of hyperlactatemia However no studies have been done to evaluate this This study proposes that high doses of vitamin B may bring elevated lactate levels back to normal among patients taking NRTIs
Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI therapy A lack of vitamin B may be related to the development of hyperlactatemia However no studies have been done to evaluate this This study proposes that high doses of vitamin B may bring elevated lactate levels back to normal among patients taking NRTIs
Detailed Description:
Hyperlactatemia with or without lactic acidosis is a potentially life-threatening condition that appears to be associated with NRTI therapy The natural history of lactate elevation as a complication of NRTI therapy is not clearly understood however some patients receiving these therapies experience a progressive increase in lactate to symptomatic levels Deficiencies in thiamine vitamin B1 and riboflavin vitamin B2 have been implicated as cofactors in producing hyperlactatemia and lactic acidosis in NRTI-treated patients A nontoxic intervention that could prevent or reverse advancing lactic acidosis and preserve NRTI use would be highly desirable To date no controlled studies have been done to examine the potential role of dietary intake B vitamin deficiency and B vitamin therapy on the pathogenesis and clinical course on NRTI-associated lactic acidosis The hypothesis proposed is that high-dose vitamin B treatment can normalize elevated lactate levels among NRTI-exposed individuals with moderately elevated lactate levels
This study consists of 2 steps Step 1 screening and Step 2 treatment Patients are screened during Step 1 for sustained hyperlactatemia and Step 2 eligibility Patients with sustained hyperlactatemia but no symptoms that indicate high risk of progression to lactic acidosis and with no plans to change existing NRTI-containing antiretroviral therapy may enter Step 2 A fasting nonexercise venous lactate level is obtained at Step 2 entry for use as a baseline measurement and every patient receives high-dose oral vitamin B1 and B2 therapy for 4 weeks Fasting nonexercise venous lactate levels are measured at Weeks 1 2 and 4 to observe the kinetics of changes in lactate levels on study treatment
This study consists of 2 steps Step 1 screening and Step 2 treatment Patients are screened during Step 1 for sustained hyperlactatemia and Step 2 eligibility Patients with sustained hyperlactatemia but no symptoms that indicate high risk of progression to lactic acidosis and with no plans to change existing NRTI-containing antiretroviral therapy may enter Step 2 A fasting nonexercise venous lactate level is obtained at Step 2 entry for use as a baseline measurement and every patient receives high-dose oral vitamin B1 and B2 therapy for 4 weeks Fasting nonexercise venous lactate levels are measured at Weeks 1 2 and 4 to observe the kinetics of changes in lactate levels on study treatment
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 |
|---|---|---|---|
| AACTG A5129 | None | None | None |