CompletedNot Applicable

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

Bangladesh72 participantsStarted 2020-11-07

Plain-language 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.

Who can participate

Age range30 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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%

What they're measuring

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

Timeframe: 8 weeks

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

Timeframe: 8 weeks

Trial details

NCT IDNCT04984044

SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31