Diabetic NeuropathyNCT02737423
Vitamin D Treatment for Painful Diabetic Neuropathy
A study testing cholecalciferol in people with Diabetic Neuropathy, run by Baqai Institute of Diabetology and Endocrinology.
Trial summary
The main objective of the study is to assess the effect of vitamin D treatment on painful diabetic neuropathy in Pakistan. This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single dose of 600,000 IU of Vitamin D. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2013
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with type 1 or type 2 diabetes aged 18 to 80 years
- Patient has a diagnosis of painful diabetic neuropathy and reports symmetrical painful symptoms in distal extremities for a period of 1-5 years prior to the study, and symptoms were attributable to DPN
- HbA1c level ≤ 11% at the screening visit were considered eligible to participate in the study.
Who cannot join
- Patients with renal impairment or hypo or hyperthyroidism,
- Patients currently taking vitamin D supplementation or anti - epileptic or anti - tuberculosis medication,
- Patients with a previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, HIV infection and peripheral neuropathy due to a non-diabetic cause
- Pregnant or breast feeding female patients
- Patients allergic to nuts or any nut products and patients participating in any other interventional research trial were excluded from the study.
About this study
Official title: Vitamin D for the Treatment of Painful Diabetic Neuropathy
The main objective of the study is to assess the effect of vitamin D treatment on painful diabetic neuropathy in Pakistan.
This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single dose of 600,000 IU of Vitamin D.
All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to participate in the study. The change in painful diabetic neuropathy scores was assessed using DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at each visit.
Read the detailed description
Background Painful diabetic neuropathy (DPN) is common in patients with long-standing diabetes mellitus. The prevalence of neuropathy approaches 50% in those with diabetes for 25 years. Among patients with neuropathy, 11.6% with type 1 diabetes and 32.1% with type 2 diabetes have neuropathic pain. In our recent observational study of a large cohort of diabetic patients from primary care in northwest England (n = 15,692), painful diabetic neuropathy (PDN), assessed using the neuropathy symptom score (NSS) and neuropathy disability score (NDS) (NSS >/=5 and NDS >/=3) was 21%, and the prevalence of painful symptoms (NSS >/=5) was 34%. Despite less neuropathy in South Asians (14%) compared to Europeans (22%) (P < 0.0001), painful symptoms were greater in South Asians (38 vs. 32%, P < 0.0001) and they maintained a 50% increased risk of painful neuropathy symptoms (P < 0.0001).
The potential for an association between vitamin D and a beneficial effect on neuropathy is based on experimental data which has shown that vitamin D3 can upregulate NGF and the products of its neuronal target genes resulting in an improvement in experimental diabetic neuropathy. Vitamin D insufficiency has recently been associated with retinopathy and self-reported peripheral neuropathy symptoms even after adjusting for demographic factors, obesity, comorbidities, use of medications for neuropathy and diabetes duration and glycemic control. Of course, there may be some overlap between the symptoms associated with vitamin D deficiency and diabetic neuropathy, which may partly explain the excess painful symptoms we have observed in Asians, particularly as the latter have excess vitamin D deficiency.
The preliminary data suggests there is an urgent need to undertake a blinded placebo-controlled randomised trial of vitamin D3 in the treatment of diabetic peripheral neuropathy.
Aims:
- To see the association of Serum Vitamin D3 levels in type 2 diabetic subjects with Painful neuropathy
- Effect of intervention through injectable Vitamin D3 on Painful diabetic neuropathy Study Design The study is a single centre, single (patient)-blinded, evaluation of injectable cholecalciferol in the treatment of painful diabetic neuropathy.
Study Drug: Injectable cholecalciferol (inj. Vitamin D3 600,000 IU).
- Sample size = 165 type 2 diabetic subjects
- Recruitment time = 12 weeks
- Treatment duration = 12 weeks
Data Analysis and Statistical Considerations:
The normality of the data will be assessed and if the data are severely non-normal, log transformations will be considered. The primary analysis will compare the change from baseline without an alpha adjustment for the multiple comparisons. Comparisons within each treatment group across time will also be considered. The analysis will be performed with Last Observation Carried Forward (LOCF).
Assessment during the Treatment Period:
- Change from baseline in DN4
- Change from baseline in SF-MPQ
- Change from baseline in NeuroQol
- Change from baseline in serum 25 (OH) D, serum corrected calcium; parathyroid hormone, serum phosphate; serum ALP
- Change from baseline in HbA1c; fasting glucose; CBC, urea, creatinine, electrolytes, urine DR, fasting lipid profile
- Conditions
- 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 Vitamin D3
Effect of Vitamin D on the symptoms of diabetic neuropathy
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Experimental | single IM dose 600,000 IU of cholecalciferol Receives: Drug: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the DN4 Neuropathic Pain Diagnostic Questionnaire
DN4 Neuropathic Pain Diagnostic Questionnaire contains six questions which reflect positive symptoms for pain i.e. question 1, 2, 3, 4, 5 and 10 (sensations of burning, painful cold, electric shocks, tingling, pins \& needles and brushing).
Measured: 5 months
Secondary outcomes (1)
Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the SF-Mac Gill Pain Questionnaire.
SF-Mac Gill pain questionnaire was evaluated to establish the sensory dimensions of pain which included pain sensations like throbbing, shooting, stabbing, sharp, cramping, gnawing, hot burning, aching, heavy, tender and splitting and effective dimensions of the pain experience which included sensations like tiring-exhausting, sickening, fearful and punishing-cruel.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqai Institute of Diabetology and Endocrinology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Basit, Baqai Institute of Diabetology and Endocrinology
- Investigators
- Abdul Basit, MRCP, Principal investigator, Baqai Institute of Diabetology and Endocrinology, Baqai Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737423
- Sponsor's protocol ID
- BIDE-12/2014
- Status last verified
- Apr 2016
- First submitted
- 1 Feb 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D for the Treatment of Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT02737423
- Acronym / sponsor ID
- BIDE-12/2014
- Conditions
- Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Baqai Institute of Diabetology and EndocrinologyUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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 the study is to assess the effect of vitamin D treatment on painful diabetic neuropathy in Pakistan.
This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single dose of 600,000 IU of Vitamin D.
All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to participate in the study. The change in painful diabetic neuropathy scores was assessed using DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at each visit.
Detailed description
Background Painful diabetic neuropathy (DPN) is common in patients with long-standing diabetes mellitus. The prevalence of neuropathy approaches 50% in those with diabetes for 25 years. Among patients with neuropathy, 11.6% with type 1 diabetes and 32.1% with type 2 diabetes have neuropathic pain. In our recent observational study of a large cohort of diabetic patients from primary care in northwest England (n = 15,692), painful diabetic neuropathy (PDN), assessed using the neuropathy symptom score (NSS) and neuropathy disability score (NDS) (NSS >/=5 and NDS >/=3) was 21%, and the prevalence of painful symptoms (NSS >/=5) was 34%. Despite less neuropathy in South Asians (14%) compared to Europeans (22%) (P < 0.0001), painful symptoms were greater in South Asians (38 vs. 32%, P < 0.0001) and they maintained a 50% increased risk of painful neuropathy symptoms (P < 0.0001).
The potential for an association between vitamin D and a beneficial effect on neuropathy is based on experimental data which has shown that vitamin D3 can upregulate NGF and the products of its neuronal target genes resulting in an improvement in experimental diabetic neuropathy. Vitamin D insufficiency has recently been associated with retinopathy and self-reported peripheral neuropathy symptoms even after adjusting for demographic factors, obesity, comorbidities, use of medications for neuropathy and diabetes duration and glycemic control. Of course, there may be some overlap between the symptoms associated with vitamin D deficiency and diabetic neuropathy, which may partly explain the excess painful symptoms we have observed in Asians, particularly as the latter have excess vitamin D deficiency.
The preliminary data suggests there is an urgent need to undertake a blinded placebo-controlled randomised trial of vitamin D3 in the treatment of diabetic peripheral neuropathy.
Aims:
- To see the association of Serum Vitamin D3 levels in type 2 diabetic subjects with Painful neuropathy
- Effect of intervention through injectable Vitamin D3 on Painful diabetic neuropathy Study Design The study is a single centre, single (patient)-blinded, evaluation of injectable cholecalciferol in the treatment of painful diabetic neuropathy.
Study Drug: Injectable cholecalciferol (inj. Vitamin D3 600,000 IU).
- Sample size = 165 type 2 diabetic subjects
- Recruitment time = 12 weeks
- Treatment duration = 12 weeks
Data Analysis and Statistical Considerations:
The normality of the data will be assessed and if the data are severely non-normal, log transformations will be considered. The primary analysis will compare the change from baseline without an alpha adjustment for the multiple comparisons. Comparisons within each treatment group across time will also be considered. The analysis will be performed with Last Observation Carried Forward (LOCF).
Assessment during the Treatment Period:
- Change from baseline in DN4
- Change from baseline in SF-MPQ
- Change from baseline in NeuroQol
- Change from baseline in serum 25 (OH) D, serum corrected calcium; parathyroid hormone, serum phosphate; serum ALP
- Change from baseline in HbA1c; fasting glucose; CBC, urea, creatinine, electrolytes, urine DR, fasting lipid profile
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Experimental | Drug: cholecalciferolsingle IM dose 600,000 IU of cholecalciferol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients with type 1 or type 2 diabetes aged 18 to 80 years
- Patient has a diagnosis of painful diabetic neuropathy and reports symmetrical painful symptoms in distal extremities for a period of 1-5 years prior to the study, and symptoms were attributable to DPN
- HbA1c level ≤ 11% at the screening visit were considered eligible to participate in the study.
Key exclusion criteria (5 listed)
- Patients with renal impairment or hypo or hyperthyroidism,
- Patients currently taking vitamin D supplementation or anti - epileptic or anti - tuberculosis medication,
- Patients with a previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, HIV infection and peripheral neuropathy due to a non-diabetic cause
- Pregnant or breast feeding female patients
- Patients allergic to nuts or any nut products and patients participating in any other interventional research trial were excluded from the study.
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: Vitamin D3Effect of Vitamin D on the symptoms of diabetic neuropathy | Drug | vitamin D |
Primary outcome
Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the DN4 Neuropathic Pain Diagnostic Questionnaire
Time frame: 5 months
DN4 Neuropathic Pain Diagnostic Questionnaire contains six questions which reflect positive symptoms for pain i.e. question 1, 2, 3, 4, 5 and 10 (sensations of burning, painful cold, electric shocks, tingling, pins \& needles and brushing).
1 secondary outcome
Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the SF-Mac Gill Pain Questionnaire.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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, MRCP principal investigator
Baqai Institute of Diabetology and Endocrinology, Baqai Medical University
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol in people with Diabetic Neuropathy, run by Baqai Institute of Diabetology and Endocrinology.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the DN4 Neuropathic Pain Diagnostic Questionnaire (time frame: 5 months). 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 14 Apr 2016.