Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy

This study has suspended participant recruitment.
(inadequate recruitment)
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00279266
First received: January 18, 2006
Last updated: October 3, 2007
Last verified: October 2007
  Purpose

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

Estimated Enrollment: 28
Study Start Date: January 2006
Estimated Study Completion Date: June 2006
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279266

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

Publications:
ClinicalTrials.gov Identifier: NCT00279266     History of Changes
Other Study ID Numbers: OSR#55288
Study First Received: January 18, 2006
Last Updated: October 3, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014