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Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT00279266
Recruitment Status : Withdrawn (inadequate recruitment)
First Posted : January 19, 2006
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Travis Losey, Loma Linda University

Brief Summary:
This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Diabetes Mellitus Diabetes Complications Drug: Thiamine Not Applicable

Detailed Description:

It is estimated that more then 5 million people in the United States suffer from Diabetes Mellitus, and of these up to 80% suffer from painful diabetic peripheral neuropathy. Multiple medications have been tried for the treatment of painful diabetic neuropathy. These medications are directed at symptomatic relief and do not address the underlying cause of painful peripheral neuropathy. Thiamine is a water-soluble vitamin that participates in carbohydrate metabolism. Deficiency of thiamine causes beriberi, characterized by painful peripheral neuropathy and cardiomyopathy. Basic research has suggested that thiamine deficiency may also be involved in the etiology of diabetic neuropathy by preventing the glycation of nerve fibers as well as apoptosis of endothelial cells. A study in the developing world found that oral thiamine and pyridoxine were helpful in improving the pain experienced in diabetic peripheral neuropathy as well as improving signs of neuropathy seen on neurological examination. A screening study of patients with type II diabetes found that 76% of patients tested had a low serum thiamine level.

Our study will examine the effect of oral thiamine supplementation on the symptom of pain in painful diabetic peripheral neuropathy. In addition we will follow serum thiamine levels to see if clinical change correlates with changes in serum thiamine levels

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Pilot Study of Oral Thiamine in the Symptomatic Treatment of Painful Diabetic Peripheral Neuropathy
Study Start Date : January 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Daily pain evaluations on a visual analog pain scale

Secondary Outcome Measures :
  1. Pain over the last 7 days as recorded on a Visual Analog pain scale
  2. Changes in Sf-36v2 results
  3. Changes in blood thiamine levels
  4. Changes in the McGill short form pain questionnaire
  5. Changes in sleep disturbance in secondary to pain as rated by a visual analog scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279266

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United States, California
Loma Linda University Department of Neurology
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
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Principal Investigator: Rodolfo Escutin, MD Loma Linda University
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Responsible Party: Travis Losey, Assistant Professor of Neurology, Loma Linda University
ClinicalTrials.gov Identifier: NCT00279266    
Other Study ID Numbers: 55288
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Travis Losey, Loma Linda University:
Diabetic Peripheral Neuropathy
Peripheral Neuropathy
Diabetes Mellitus
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vitamin B Complex
Physiological Effects of Drugs