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

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ClinicalTrials.gov Identifier: NCT04984044
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Zannatul Ferdous, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Not Applicable

Detailed Description:
Diabetic peripheral neuropathy(DPN) is one of the common complications of long-standing diabetes mellitus with a prevalence of 30 to 50%. Progressive pain, numbness, sensory and motor deficit accelerates the occurrence of ulcers of the diabetic foot and amputation of lower extremities which severely affects the quality of life. The incidence and prevalence rate is rising worldwide including in Bangladesh. 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. Recent studies have proved that there is an apparent vitamin D deficiency in diabetic peripheral neuropathy patients. However, some recent trials attempted to assess the effect of vitamin D supplementation to improve patient's pain symptoms and neurologic function. Most of them showed positive findings. Aim: This proposed study is therefore an effort whether there is any role of vitamin D in improving symptoms of diabetic peripheral neuropathy patients. Method: This study will be a randomized, double-blind, placebo-controlled trial. It will be conducted in the department of pharmacology, BSMMU in collaboration with the department of endocrinology, BSMMU in between September 2020 to February 2021. A total of 78 patients suffering from diabetic peripheral neuropathy will be selected according to inclusion and exclusion criteria. The diagnosis of diabetic peripheral neuropathy will be performed by a consultant of the endocrinology department. A validated version of the visual analogue scale (VAS) and MNSI will be used to assess patients at baseline after 8 weeks. The patients will be enrolled and randomly allocated in two arms: control and intervention. The patient in the control arm will receive a placebo for 8 weeks starting after the day of the initial assessment. On the other hand intervention arm will receive vitamin D (40,000 IU) weekly orally. Blood samples will be collected to measure serum vitamin D level at baseline and again after 8 weeks of therapeutic intervention. Regularity of medicine intake will be ensured over the telephone, pill count, and from the patient's compliance sheet. Statistical analysis: Statistical analysis will be done by SPSS version 24. Unpaired 't' test will be done to compare between two means of interventional group and placebo group. Paired 't' test will be done to compare between two means before and after the intervention. Proportion test 'Z' will be done to compare the proportion between the intervention group and placebo group. The calculated 'p' value may suggest the level of significance (significant at p < 0.05). Ethical consideration: After approval from IRB every eligible patient will be informed about the intervention and the study from IRB every eligible patient will be informed about the intervention and the study objectives. The patient will also be informed that they can participate in this study of their free will and also they are free to refuse to participate or to withdraw at any time without compromising their medical care. Patients who will take part in the study willingly with written consent will be interviewed. The patient's confidentiality will be strictly maintained. The patient's personal data regarding the name, age, sex, and other information will not be disclosed anywhere and will only be used for research purposes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Diagnosed case of Type 1 and Type 2 Diabetes Mellitus
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms
Actual Study Start Date : November 7, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental
This arm includes 39 Diabetic Peripheral Neuropathy patients receiving the antidiabetic therapy
Dietary Supplement: Vitamin D3

Dietary supplement:Vitamin D3

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

Other Name: Cholecalciferol

Placebo Comparator: Control
This arm includes 39 Diabetic Peripheral Neuropathy patients receiving the antidiabetic therapy
Dietary Supplement: Placebo
1 capsule weekly for 8 weeks with antidiabetic drug




Primary Outcome Measures :
  1. Change from baseline Visual Analogue Scale(VAS) score at 8 weeks. [ Time Frame: 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).

  2. Change from baseline Michigan Neuropathy Screening Instrument (MNSI) scores at 8 weeks. [ Time Frame: 8 weeks ]
    Assessment of severity of neuropathic symptoms by using MNSI score at baseline and after 8 weeks and compare the score between two groups. MNSI is composed of 15 items questionnaire. MNSI score of more than 7 indicates the presence of diabetic neuropathy. 13 is the highest score indicating the worst disease.


Secondary Outcome Measures :
  1. Change from baseline Serum 25(OH) D level at 8 weeks. [ Time Frame: 8 weeks ]
    Serum 25(OH) D level is assessed at baseline and 8 weeks following vitamin D administration. Compare the serum 25(OH) D level between two groups.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Type I and Type II Diabetes Mellitus patients who have been on stable anti-diabetic therapy for 1 year or more
  • Diabetic patient who meet the clinical criteria for DPN
  • Age between 18 and 70 years
  • Gender: Both Male and Female
  • Serum 25(OH) D < 30 ng/ml

Exclusion Criteria:

  • Patients suffering from other causes of peripheral neuropathy for example chemotherapy, hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism, vitamin B 12 deficiency, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984044


Contacts
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Contact: Zannatul Ferdous, MBBS 01726217811 zannatul.rpmc@gmail.com
Contact: Tanvir Siddiquee, MSc CSE 01712560297 tanvirhstu@gmail.com

Locations
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Bangladesh
Department of Pharmacology, BSMMU Recruiting
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Principal Investigator: Zannatul Ferdous, MBBS Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Chair: Prof. Md. Sayedur Rahman, MBBS M Phil Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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Responsible Party: Dr. Zannatul Ferdous, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT04984044    
Other Study ID Numbers: BSMMU/2020/9630
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Zannatul Ferdous, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
DPN
Vitamin D3
MNSI
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents