Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (inadequate recruitment)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

January 18, 2006
January 19, 2006
May 13, 2015
January 2006
June 2006   (Final data collection date for primary outcome measure)
Daily pain evaluations on a visual analog pain scale
Same as current
Complete list of historical versions of study NCT00279266 on Archive Site
  • 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
Same as current
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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
This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.

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

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Peripheral Neuropathy
  • Diabetes Mellitus
  • Diabetes Complications
Drug: Thiamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2006
June 2006   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Travis Losey, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Rodolfo Escutin, MD Loma Linda University
Loma Linda University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP