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 range

30 Years – 70 Years

Sex

ALL

See this in plain English?

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%

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials