Painful Diabetic NeuropathyNCT05080530
Vitamin D and Painful Diabetic Neuropathy
A study testing Cholecalciferol in people with Painful Diabetic Neuropathy, run by Baqai Institute of Diabetology and Endocrinology at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Oct 2021to 20 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insulin dependent diabetes
- Insulin independent diabetes
- Age range between 25 to 80 years
- Glycated hemoglobin (HbA1c) level must be ≥ 6.5%
- Apparently no symptoms of Vitamin D Deficiency
Who cannot join
- History of hyperparathyroidism
- Pregnant women
- Lactating mothers
- History for rickets and osteomalacia
- On Vitamin D supplementation
- On Multivitamin
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- On anti-epileptics
- On steroids
- On bisphosphonates
- On oral contraceptives
- Subjects who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Baqai Institute of Diabetology and Endocrinology (BIDE)
Karachi, Sindh, 74600
Abdul Basit, Professor, 009221-36707179, research@bide.edu.pk
Asher Fawwad, Professor, 009221-36707179, asherfawwad@bide.edu.pk
About this study
Official title: Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
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.
Read the 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
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Cholecalciferol
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Sunny D™ (Vitamin D3) Softgel Capsule
Effect of Vitamin D on diabetic neuropathy symptoms
| Study group | Role | What they receive |
|---|---|---|
| 1. Normal Vit D (> 30ng/mL) | No intervention | Follow-up after 3 months with standard treatment |
| 2. Insufficient Vit D (20-30ng/mL) | Experimental | single oral dose capsule 200,000 IU of Cholecalciferol Receives: Drug: Cholecalciferol |
| 3. Insufficient Vit D (20-30ng/mL) | No intervention | Follow-up after 3 months with standard treatment |
| 4. Deficient Vit D | Experimental | single oral dose capsule 200,000 IU of Cholecalciferol Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in DN4 score.
The change will be observed with the help of neuropathic pain assessment questionnaire.
Measured: 3 months
Change from baseline in serum HbA1c.
The change will be observed in the serum values of glycated hemoglobin at the end point after the administration of vitamin D.
Measured: 3 months
Change from baseline in serum vitamin D.
The cholecalciferol (Vitamin D) level in serum will be observed at the end point after the administration of vitamin D.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start29 Oct 2021
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqai Institute of Diabetology and Endocrinology
- Sponsor type
- University, hospital or other
- Collaborators
- Scotmann Pharmaceuticals
- Responsible party
- Principal investigator, Abdul Basit, Baqai Institute of Diabetology and Endocrinology
- Investigators
- Abdul Basit, Director, Principal investigator, Baqai Institute of Diabetology and Endocrinology (BIDE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080530
- Sponsor's protocol ID
- BIDE-216D/2021
- Status last verified
- Jul 2022
- First submitted
- 29 Sep 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05080530
- Acronym / sponsor ID
- BIDE-216D/2021
- Conditions
- Painful Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Baqai Institute of Diabetology and EndocrinologyUniversity, hospital or other
- Collaborators
- Scotmann Pharmaceuticals
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Aug 2022 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Normal Vit D (> 30ng/mL) | No intervention | –Follow-up after 3 months with standard treatment |
| 2. Insufficient Vit D (20-30ng/mL) | Experimental | Drug: Cholecalciferolsingle oral dose capsule 200,000 IU of Cholecalciferol |
| 3. Insufficient Vit D (20-30ng/mL) | No intervention | –Follow-up after 3 months with standard treatment |
| 4. Deficient Vit D | Experimental | Drug: Cholecalciferolsingle oral dose capsule 200,000 IU of Cholecalciferol |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Insulin dependent diabetes
- Insulin independent diabetes
- Age range between 25 to 80 years
- Glycated hemoglobin (HbA1c) level must be ≥ 6.5%
- Apparently no symptoms of Vitamin D Deficiency
Key exclusion criteria (11 listed)
- History of hyperparathyroidism
- Pregnant women
- Lactating mothers
- History for rickets and osteomalacia
- On Vitamin D supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: Sunny D™ (Vitamin D3) Softgel CapsuleEffect of Vitamin D on diabetic neuropathy symptoms | Drug | 2. Insufficient Vit D (20-30ng/mL), 4. Deficient Vit D |
Primary outcome
Change from baseline in DN4 score.
Time frame: 3 months
The change will be observed with the help of neuropathic pain assessment questionnaire.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Basit, Director principal investigator
Baqai Institute of Diabetology and Endocrinology (BIDE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Painful Diabetic Neuropathy, run by Baqai Institute of Diabetology and Endocrinology at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdul Basit, Professor (009221-36707179, research@bide.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in DN4 score. (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.