Study Stopped
inadequate recruitment
Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy
A Randomized Double Blinded Pilot Study of Oral Thiamine in the Symptomatic Treatment of Painful Diabetic Peripheral Neuropathy
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 18, 2006
CompletedFirst Posted
Study publicly available on registry
January 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMay 13, 2015
May 1, 2015
5 months
January 18, 2006
May 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Daily pain evaluations on a visual analog pain scale
Secondary Outcomes (5)
Pain over the last 7 days as recorded on a Visual Analog pain scale
Changes in Sf-36v2 results
Changes in blood thiamine levels
Changes in the McGill short form pain questionnaire
Changes in sleep disturbance in secondary to pain as rated by a visual analog scale
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Diabetes Mellitus Painful diabetic neuropathy for \> six months with a score of \>40mm on a visual pain analog scale Age \>18 years Hemoglobin A1c obtained within the last 3 months. Willingness and ability to comply with the study requirements and give informed consent.
You may not qualify if:
- Known history of alcohol abuse, recreational drug abuse, thyroid dysfunction, syphilis, multiple myeloma, known nutrient deficiency, history of gastric bypass surgery or HIV. Hgb A1c\>11
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University Department of Neurology
Loma Linda, California, 92354, United States
Related Publications (2)
Thornalley PJ. Glycation in diabetic neuropathy: characteristics, consequences, causes, and therapeutic options. Int Rev Neurobiol. 2002;50:37-57. doi: 10.1016/s0074-7742(02)50072-6.
PMID: 12198817BACKGROUNDAbbas ZG, Swai AB. Evaluation of the efficacy of thiamine and pyridoxine in the treatment of symptomatic diabetic peripheral neuropathy. East Afr Med J. 1997 Dec;74(12):803-8.
PMID: 9557427BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodolfo Escutin, MD
Loma Linda University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
January 18, 2006
First Posted
January 19, 2006
Study Start
January 1, 2006
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
May 13, 2015
Record last verified: 2015-05