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Vitamin D Treatment for Painful Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT02737423
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Abdul Basit, Baqai Institute of Diabetology and Endocrinology

Brief 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.

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.


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

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).

  1. Sample size = 165 type 2 diabetic subjects
  2. Recruitment time = 12 weeks
  3. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vitamin D for the Treatment of Painful Diabetic Neuropathy
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vitamin D
single IM dose 600,000 IU of cholecalciferol
Drug: cholecalciferol
Effect of Vitamin D on the symptoms of diabetic neuropathy
Other Name: Vitamin D3




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT02737423


Sponsors and Collaborators
Baqai Institute of Diabetology and Endocrinology
Investigators
Layout table for investigator information
Principal Investigator: Abdul Basit, MRCP Baqai Institute of Diabetology and Endocrinology, Baqai Medical University

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Responsible Party: Abdul Basit, Professor of Medicine, Director of Baqai Institute of Diabetology and Endocrinology, Baqai Institute of Diabetology and Endocrinology
ClinicalTrials.gov Identifier: NCT02737423    
Other Study ID Numbers: BIDE-12/2014
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents