Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-26 @ 5:01 PM
Study NCT ID:
NCT00031057
Status:
COMPLETED
Last Update Posted:
2011-02-28
First Post:
2002-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin B Therapy for Hyperlactatemia
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AACTG A5129 | None | None | View |