Trial record 13 of 1666 for:    Peripheral Neuropathy

Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy

This study has been withdrawn prior to enrollment.
(inadequate recruitment)
Information provided by (Responsible Party):
Travis Losey, Loma Linda University Identifier:
First received: January 18, 2006
Last updated: May 11, 2015
Last verified: May 2015

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

Condition Intervention
Peripheral Neuropathy
Diabetes Mellitus
Diabetes Complications
Drug: Thiamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Pilot Study of Oral Thiamine in the Symptomatic Treatment of Painful Diabetic Peripheral Neuropathy

Resource links provided by NLM:

Further study details as provided by Loma Linda University:

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

Secondary Outcome Measures:
  • 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

Enrollment: 0
Study Start Date: January 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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Please refer to this study by its identifier: NCT00279266

United States, California
Loma Linda University Department of Neurology
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Principal Investigator: Rodolfo Escutin, MD Loma Linda University
  More Information

Responsible Party: Travis Losey, Assistant Professor of Neurology, Loma Linda University Identifier: NCT00279266     History of Changes
Other Study ID Numbers: 55288
Study First Received: January 18, 2006
Last Updated: May 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Diabetic Peripheral Neuropathy
Peripheral Neuropathy
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins processed this record on October 06, 2015