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

NCT ID: NCT04689958

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-03

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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This was randomized clinical trial, active comparator, open label, controlled study from the period of November 2020 - November 2021 at Bethesda Hospital, Yogyakarta, Indonesia.

There were 60 painful diabetic neuropathy patients who fulfilled the inclusion and exclusion criteria. Each subject had been followed up from the first day of medication administration until 8 weeks after medication administration.

Ethical approval number ((kosong)) was obtained from Health Research Ethics Committee, Bethesda Hospital Yogyakarta.

The hypothesis of this study:

a. Add on oral vitamin D 5000 IU to standard treatment in patients with painful diabetic neuropathy is more effective in reducing pain and neuropathic symptoms in 8 weeks of treatment compared with standard treatment, b. Add on oral vitamin D 5000 IU to standard treatment in patients with painful diabetic neuropathy is as safe as standard treatment.

Conditions

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Painful Diabetic Neuropathy

Keywords

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Vitamin D Standard therapy Neuropathy Diabetic neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Standard therapy

Intervention Type DRUG

Gabapentin, pregabalin, or amitriptyline

Vitamin D 5,000IU Oral Tablet

Intervention Type DRUG

Vitamin D 5000 IU oral tablet once daily

Control Group

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline

Group Type ACTIVE_COMPARATOR

Standard therapy

Intervention Type DRUG

Gabapentin, pregabalin, or amitriptyline

Interventions

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Standard therapy

Gabapentin, pregabalin, or amitriptyline

Intervention Type DRUG

Vitamin D 5,000IU Oral Tablet

Vitamin D 5000 IU oral tablet once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PT SOHO Global Health Tbk

UNKNOWN

Sponsor Role collaborator

Duta Wacana Christian University

OTHER

Sponsor Role lead

Responsible Party

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Rizaldy Taslim Pinzon

Principal investigator, Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rizaldy T Pinzon, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Duta Wacana Christian University

Locations

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Bethesda Hospital Yogyakarta

Yogyakarta, Special Region of Yogyakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Rizaldy T Pinzon, MD, MSc, PhD

Role: CONTACT

Phone: +62 81294638229

Email: [email protected]

Vanessa Veronica, BM

Role: CONTACT

Phone: +62 89605559529

Email: [email protected]

Facility Contacts

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Rizaldy T Pinzon, MD, MSc, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30641826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25720672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22050401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21726279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16112498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18413561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23304571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27026808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29445752 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34984028 (View on PubMed)

Other Identifiers

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VITAMIND5000IU

Identifier Type: -

Identifier Source: org_study_id