Vitamin D Treatment for Painful Diabetic Neuropathy

NCT02737423 | Completed DMC

• 1 other identifier: BIDE-12/2014
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of the study is to assess the effect of vitamin D treatment on painful diabetic neuropathy in Pakistan. This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single dose of 600,000 IU of Vitamin D. All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to participate in the study. The change in painful diabetic neuropathy scores was assessed using DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at each visit.

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the DN4 Neuropathic Pain Diagnostic Questionnaire

  DN4 Neuropathic Pain Diagnostic Questionnaire contains six questions which reflect positive symptoms for pain i.e. question 1, 2, 3, 4, 5 and 10 (sensations of burning, painful cold, electric shocks, tingling, pins \& needles and brushing).

  5 months

Secondary Outcomes (1)

• Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the SF-Mac Gill Pain Questionnaire.

  5 months

Study Arms (1)

vitamin D

EXPERIMENTAL

single IM dose 600,000 IU of cholecalciferol

Drug: cholecalciferol

Interventions

cholecalciferol DRUG

Effect of Vitamin D on the symptoms of diabetic neuropathy

Also known as: Vitamin D3

vitamin D

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with type 1 or type 2 diabetes aged 18 to 80 years
• Patient has a diagnosis of painful diabetic neuropathy and reports symmetrical painful symptoms in distal extremities for a period of 1-5 years prior to the study, and symptoms were attributable to DPN
• HbA1c level ≤ 11% at the screening visit were considered eligible to participate in the study.

You may not qualify if:

• Patients with renal impairment or hypo or hyperthyroidism,
• Patients currently taking vitamin D supplementation or anti - epileptic or anti - tuberculosis medication,
• Patients with a previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, HIV infection and peripheral neuropathy due to a non-diabetic cause
• Pregnant or breast feeding female patients
• Patients allergic to nuts or any nut products and patients participating in any other interventional research trial were excluded from the study.

Sponsors & Collaborators

• Baqai Institute of Diabetology and Endocrinology: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Abdul Basit, MRCP

  Baqai Institute of Diabetology and Endocrinology, Baqai Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director of Baqai Institute of Diabetology and Endocrinology

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: April 14, 2016
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 14, 2016

Record last verified: 2016-04