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Vitamin D and Painful Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT05080530
Recruitment Status : Not yet recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Abdul Basit, Baqai Institute of Diabetology and Endocrinology

Brief Summary:

The main objective of this study is to evaluate the effect of vitamin D3 on diabetic individual with painful neuropathy in a tertiary healthcare.

The people with diabetes (type 1 and type 2) who have a Douleur Neuropathique 4 (DN4) score ≥4 will be considered eligible in this prospective study. Their serum samples will be subjected to pre-and post-biochemical screening of serum 25 (OH) D and HbA1c. The individual having Vitamin D insufficiency and deficiency will be administered a single dose of oral Vitamin D3 (Soft Gel capsule 200,000 IU), and follow-up for post-biochemical screening after 3 months.


Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Drug: Cholecalciferol Not Applicable

Detailed Description:

Painful diabetic neuropathy (PDN) is the most common diabetic complication in patients who have had diabetes mellitus for a long time. Diabetic peripheral neuropathy is the common cause of neuropathy globally. About 50-60% of individuals with long-term diabetes develop diabetic neuropathy. Several recent observational studies in diabetic individuals have provided a correlation between vitamin D insufficiency and diabetes. Despite the fact that the pathogenesis of diabetic neuropathy is complex, recent investigations revealed that deficiency of vitamin D is an important factor in the development of diabetic neuropathy. Also, vitamin D supplementation was found to be effective in treating neuropathic pain and preventing neuronal degeneration.

Aims and Objectives:

The assessment of the effect of single-dose, oral vitamin D in patients with painful diabetic neuropathy.

Materials and Methods:

Study Drug: Oral cholecalciferol (Vitamin D3 capsule 200,000 IU).

A single oral dose of 200000 IU vitamin D will be administered in people with diabetic neuropathy, and the effect will be observed after 3 months.

  • Sample size = 216 type 1 and 2 diabetic subjects
  • Recruitment time = 4 months
  • Treatment duration = 3 months

Ethical Approval:

The ethical approval for this study will be taken from the Institutional Review Board (IRB) of Baqai Institute of Diabetology and Endocrinology (BIDE)

Study Area and Duration:

This study is going to be conducted from October 2021 to March 2022 in the outpatient department (OPD) of BIDE.

Data Analysis and Statistics:

The primary analysis will compare the change from baseline. Comparisons within each treatment group across time will also be considered. The analysis will be performed with the Statistical Package for the Social Sciences (SPSS).

Assessment during the Treatment Period:

  • Change from baseline in DN4
  • Change from baseline in serum 25 (OH) D,
  • Change from baseline in HbA1c

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 1. Normal Vit D (> 30ng/mL)
Follow-up after 3 months with standard treatment
Experimental: 2. Insufficient Vit D (20-30ng/mL)
single oral dose capsule 200,000 IU of Cholecalciferol
Drug: Cholecalciferol
Effect of Vitamin D on diabetic neuropathy symptoms
Other Name: Sunny D™ (Vitamin D3) Softgel Capsule

No Intervention: 3. Insufficient Vit D (20-30ng/mL)
Follow-up after 3 months with standard treatment
Experimental: 4. Deficient Vit D
single oral dose capsule 200,000 IU of Cholecalciferol
Drug: Cholecalciferol
Effect of Vitamin D on diabetic neuropathy symptoms
Other Name: Sunny D™ (Vitamin D3) Softgel Capsule




Primary Outcome Measures :
  1. Change from baseline in DN4 score. [ Time Frame: 3 months ]
    The change will be observed with the help of neuropathic pain assessment questionnaire.

  2. Change from baseline in serum HbA1c. [ Time Frame: 3 months ]
    The change will be observed in the serum values of glycated hemoglobin at the end point after the administration of vitamin D.

  3. Change from baseline in serum vitamin D. [ Time Frame: 3 months ]
    The cholecalciferol (Vitamin D) level in serum will be observed at the end point after the administration of vitamin D.



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin dependent diabetes
  • Insulin independent diabetes
  • Age range between 25 to 80 years
  • Glycated hemoglobin (HbA1c) level must be ≤11%
  • Apparently no symptoms of Vitamin D Deficiency

Exclusion Criteria:

  • History of hyperparathyroidism
  • Pregnant women
  • Lactating mothers
  • History for rickets and osteomalacia
  • On Vitamin D supplementation
  • On Multivitamin
  • On anti-epileptics
  • On steroids
  • On bisphosphonates
  • On oral contraceptives
  • Subjects who refuse to participate in the study

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): NCT05080530


Contacts
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Contact: Abdul Basit, Professor 009221-36707179 research@bide.edu.pk
Contact: Asher Fawwad, Professor 009221-36707179 asherfawwad@bide.edu.pk

Sponsors and Collaborators
Baqai Institute of Diabetology and Endocrinology
Investigators
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Principal Investigator: Abdul Basit, Director Baqai Institute of Diabetology and Endocrinology (BIDE)
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Responsible Party: Abdul Basit, Professor of Medicine, and Director, Baqai Institute of Diabetology and Endocrinology
ClinicalTrials.gov Identifier: NCT05080530    
Other Study ID Numbers: BIDE-216D/2021
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents