Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms

NCT04984044 | Completed

• 1 other identifier: BSMMU/2020/9630
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic peripheral neuropathy(DPN) is one of the major complications of diabetes mellitus which accelerates the occurrence of ulceration of diabetic foot and amputation of lower extremities as well as severely affects the quality of life. The treatment of this condition has remained unsatisfactory with a good response to conventional medications. It is now evident that vitamin D deficiency is common in diabetic patients and especially in these patients diagnosed with diabetic peripheral neuropathy. The present research is therefore designed to observe the effect of exogenous administration of vitamin D in diabetic peripheral neuropathy patients of Bangladesh.

Conditions

Diabetic Peripheral Neuropathy

Keywords

DPN; Vitamin D3; MNSI

Outcome Measures

Primary Outcomes (2)

• Change from baseline Visual Analogue Scale(VAS) score at 8 weeks.

  Assessment of severity of pain by using Visual Analogue Scale(VAS) at baseline and after 8 weeks and compare the score between two groups. VAS is a 0-10 numeric pain scale scored by No pain (score 0-3), moderate pain (scoring 4-6), and unbearable pain (score 7-10).

  8 weeks

• Change from baseline Michigan Neuropathy Screening Instrument (MNSI) scores at 8 weeks.

  Assessment of severity of neuropathic symptoms by using MNSI score at baseline and after 8 weeks and comparing the score between two groups. MNSI is composed of 15 items questionnaire and a brief clinical examination. MNSI questionnaire score of 7 or more indicates the presence of diabetic peripheral neuropathy. 13 is the highest score indicating the worst disease. Whereas, MNSI Physical assessment score of 2.5 or more indicates the presence of diabetic peripheral neuropathy.

  8 weeks

Secondary Outcomes (1)

• Change from baseline Serum 25(OH) D level at 8 weeks.

  8 weeks

Study Arms (2)

Experimental

ACTIVE COMPARATOR

This arm includes 36 Diabetic Peripheral Neuropathy patients receiving the antidiabetic medications

Dietary Supplement: Vitamin D3

Control

PLACEBO COMPARATOR

This arm includes 36 Diabetic Peripheral Neuropathy patients receiving the antidiabetic medications

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Dietary supplement:Vitamin D3 1 capsule of Vitamin D3 (40,000IU) weekly for 8 weeks with antidiabetic drug

Also known as: Cholecalciferol

Experimental

Placebo DIETARY_SUPPLEMENT

1 capsule weekly for 8 weeks with antidiabetic drug

Control

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Type II Diabetes Mellitus patients who have been on anti-diabetic therapy for 1 year or more
• Diabetic patient who meet the clinical criteria for DPN diagnosed by an endocrinologist of OPD of endocrinology
• Age between 30 and 70 years
• Gender: Both Male and Female
• Patients who will give informed written consent

You may not qualify if:

• Patients suffering from other causes of peripheral neuropathy for example chemotherapy-induced neuropathy, hyperthyroidism or hypothyroidism, rheumatoid arthritis, SLE
• Pregnant or lactating women
• Patients with renal and liver disease, psychiatric disorder
• Patients receiving vitamin D, vitamin B6, vitamin B12 supplementation, anticonvulsants, antidepressants, opioids, and other neuropathic pain medications within the last two months.
• Serum calcium level: \> 10.2 mg/dl
• HbA1c level \> 11%

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Department of Pharmacology, BSMMU

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zannatul Ferdous, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

• Prof. Md. Sayedur Rahman, MBBS, M Phil, FCPS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Diagnosed case of Type 2 Diabetes Mellitus with peripheral neuropathy

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: July 30, 2021
• Study Start: November 7, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

BA (1)