The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

NCT04689958 | Unknown Phase 2

• 1 other identifier: VITAMIND5000IU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic neuropathy is one of the micro-vascular complications of diabetes, 30-50% occurring in all diabetic patients. This complication is one of the major cause of morbidity and mortality in diabetic patientsand leading to a deterioration of their quality life. A deficiency of vitamin D \[25-hydroxyvitamin D, 25(OH) D\] is common in patient with diabetes and low concentrations are associated with the presence and severity of sensory neuropathy in diabetes. Vitamin D deficiency has been shown to be an independent risk factor for diabetic peripheral neuropathy (DPN). Topical and oral vitamin D have been reported significantly reduce the symptoms and the pain of DPN. However, no case control clinical trial have been reported that demonstrate the efficacy of vitamin D supplementation on the symptoms of DPN. Painful in diabetic neuropathy is a major complication of diabetes, characterized by pain, tingling, burning and cramps in the lower legs and feet with a signification reduction in quality of life. Recently, there shown a significant reduction in the severity of painful diabetic neuropathy after treatment with vitamin D. Patient with diabetes have a poor quality of life compared to person without diabetes. The current study assessed the benefits of add on oral vitamin D 5000 IU on diabetic neuropathy patient to pain impact in daily life.

Conditions

Painful Diabetic Neuropathy

Keywords

Vitamin D; Standard therapy; Neuropathy; Diabetic neuropathy

Outcome Measures

Primary Outcomes (6)

• Improvement in Visual Analogue Scale (VAS) at week 4

  Change in pain impact on daily life as measured by Visual Analogue Scale (VAS) from its baseline value. Visual analogue scale is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100). The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  4 weeks after treatment initiation

• Improvement in Visual Analogue Scale (VAS) at week 8

  Change in pain impact on daily life as measured by Visual Analogue Scale (VAS) from its baseline and week 4 value. Visual analogue scale is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100). The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  8 weeks after treatment initiation

• Improvement in Numeric Pain Scale at week 4

  Change in pain impact on daily life as measured by Numeric Pain Scale from its baseline value. Numeric pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.

  4 weeks after treatment initiation

• Improvement in Numeric Pain Scale at week 8

  Change in pain impact on daily life as measured by Numeric Pain Scale from its baseline and week 4 value. Numeric pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.

  8 weeks after treatment initiation

• Improvement in Brief Pain inventory at week 4

  Change in pain impact on daily life as measured by Brief Pain Inventory from its baseline value. The Brief Pain Inventory evaluates a patient's pain experience through a number of different scales. There are line drawings of the front and back of a human body on which patients mark the location of their pain. Patients are asked to list the treatments or medications that they are using and how much relief they have provided in the past 24 hours. In addition, patients fill out 11 different numeric rating scale that ask about pain intensity (ranging from 0 to 10) and the effect of the pain on their ability to function during various activities of daily living. A higher score indicates greater pain intensity.

  4 weeks after treatment initiation

• Improvement in Brief Pain inventory at week 8

  Change in pain impact on daily life as measured by Brief Pain Inventory from its baseline and week 4 value. The Brief Pain Inventory evaluates a patient's pain experience through a number of different scales. There are line drawings of the front and back of a human body on which patients mark the location of their pain. Patients are asked to list the treatments or medications that they are using and how much relief they have provided in the past 24 hours. In addition, patients fill out 11 different numeric rating scale that ask about pain intensity (ranging from 0 to 10) and the effect of the pain on their ability to function during various activities of daily living. A higher score indicates greater pain intensity.

  8 weeks after treatment initiation

Study Arms (2)

Experimental Group

EXPERIMENTAL

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline and vitamin D 5000 IU once daily (experimental group).

Drug: Standard therapy; Drug: Vitamin D 5,000IU Oral Tablet

Control Group

ACTIVE COMPARATOR

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline

Drug: Standard therapy

Interventions

Standard therapy DRUG

Gabapentin, pregabalin, or amitriptyline

Control Group; Experimental Group

Vitamin D 5,000IU Oral Tablet DRUG

Vitamin D 5000 IU oral tablet once daily

Experimental Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Adult age (\>18 years old)
• Diagnosed as painful diabetic neuropathy based on validated Diabetic Neuropathy Symptoms (DNS) and Diabetic Neuropathy Examination (DNE)
• Low vitamin D status of \<30 ng/ml

You may not qualify if:

• Subjects with significant renal and liver problem
• Subjects with known hypersensitivity to vitamin D 5000 IU
• Pregnancy and breastfeeding patients
• Patients that enrolled any clinical trial within a month
• Not competent enough in giving approval and answering questionnaires

Sponsors & Collaborators

• Duta Wacana Christian University: lead
• PT SOHO Global Health Tbk: collaborator

Study Sites (1)

Bethesda Hospital Yogyakarta

Yogyakarta, Special Region of Yogyakarta, 55224, Indonesia

RECRUITING

Related Publications (10)

• Ghadiri-Anari A, Mozafari Z, Gholami S, Khodaei SA, Aboutorabi-Zarchi M, Sepehri F, Nadjarzade A, Rahmanian M, Namiranian N. Dose vitamin D supplementations improve peripheral diabetic neuropathy? A before-after clinical trial. Diabetes Metab Syndr. 2019 Jan-Feb;13(1):890-893. doi: 10.1016/j.dsx.2018.12.014. Epub 2018 Dec 20.

  PMID: 30641826 BACKGROUND

• Shehab D, Al-Jarallah K, Abdella N, Mojiminiyi OA, Al Mohamedy H. Prospective evaluation of the effect of short-term oral vitamin d supplementation on peripheral neuropathy in type 2 diabetes mellitus. Med Princ Pract. 2015;24(3):250-6. doi: 10.1159/000375304. Epub 2015 Feb 26.

  PMID: 25720672 BACKGROUND

• Shehab D, Al-Jarallah K, Mojiminiyi OA, Al Mohamedy H, Abdella NA. Does Vitamin D deficiency play a role in peripheral neuropathy in Type 2 diabetes? Diabet Med. 2012 Jan;29(1):43-9. doi: 10.1111/j.1464-5491.2011.03510.x.

  PMID: 22050401 BACKGROUND

• Soderstrom LH, Johnson SP, Diaz VA, Mainous AG 3rd. Association between vitamin D and diabetic neuropathy in a nationally representative sample: results from 2001-2004 NHANES. Diabet Med. 2012 Jan;29(1):50-5. doi: 10.1111/j.1464-5491.2011.03379.x.

  PMID: 21726279 BACKGROUND

• Valensi P, Le Devehat C, Richard JL, Farez C, Khodabandehlou T, Rosenbloom RA, LeFante C. A multicenter, double-blind, safety study of QR-333 for the treatment of symptomatic diabetic peripheral neuropathy. A preliminary report. J Diabetes Complications. 2005 Sep-Oct;19(5):247-53. doi: 10.1016/j.jdiacomp.2005.05.011.

  PMID: 16112498 BACKGROUND

• Lee P, Chen R. Vitamin D as an analgesic for patients with type 2 diabetes and neuropathic pain. Arch Intern Med. 2008 Apr 14;168(7):771-2. doi: 10.1001/archinte.168.7.771. No abstract available.

  PMID: 18413561 BACKGROUND

• Bell DS. Reversal of the Symptoms of Diabetic Neuropathy through Correction of Vitamin D Deficiency in a Type 1 Diabetic Patient. Case Rep Endocrinol. 2012;2012:165056. doi: 10.1155/2012/165056. Epub 2012 Dec 12.

  PMID: 23304571 BACKGROUND

• Basit A, Basit KA, Fawwad A, Shaheen F, Fatima N, Petropoulos IN, Alam U, Malik RA. Vitamin D for the treatment of painful diabetic neuropathy. BMJ Open Diabetes Res Care. 2016 Feb 10;4(1):e000148. doi: 10.1136/bmjdrc-2015-000148. eCollection 2016.

  PMID: 27026808 BACKGROUND

• Alam U, Fawwad A, Shaheen F, Tahir B, Basit A, Malik RA. Improvement in Neuropathy Specific Quality of Life in Patients with Diabetes after Vitamin D Supplementation. J Diabetes Res. 2017;2017:7928083. doi: 10.1155/2017/7928083. Epub 2017 Dec 28.

  PMID: 29445752 BACKGROUND

• Pinzon RT, Wijaya VO, Veronica V. The Benefits of Add-on Therapy of Vitamin D 5000 IU to the Vitamin D Levels and Symptoms in Diabetic Neuropathy Patients: A Randomized Clinical Trial. J Pain Res. 2021 Dec 19;14:3865-3875. doi: 10.2147/JPR.S341862. eCollection 2021.

  PMID: 34984028 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Standard of Care; Vitamin D; Tablets

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Rizaldy T Pinzon, MD, MSc, PhD

  Duta Wacana Christian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rizaldy T Pinzon, MD, MSc, PhD

CONTACT

+62 81294638229; drpinzon17@gmail.com

Vanessa Veronica, BM

CONTACT

+62 89605559529; vanessaveronica73@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Neurologist

Model Details: Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin D 5000 IU tablet once daily (experimental group).

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 30, 2020
• Study Start: November 3, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)