Vitamin D in Diabetic Neuropathy

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTanta University

About this trial

Introduction Diabetic peripheral neuropathy (DPN) is among the most common chronic complications of diabetes mellitus and represents a major cause of morbidity, impaired quality of life, sleep disturbance, chronic pain, and functional disability.(Kurz et al., 2026) The pathogenesis of DPN is multifactorial and involves oxidative stress, chronic inflammation, endothelial dysfunction, mitochondrial injury, and microvascular ischemia, leading to progressive nerve damage.(Yang et al., 2025) Despite the availability of symptomatic therapies such as gabapentin, pregabalin, and duloxetine, many patients continue to experience persistent neuropathic symptoms, poor sleep quality, and impaired daily functioning. Existing pharmacological therapies are often associated with incomplete response, adverse effects, and high economic burden.(Kaye et al., 2025) Recently, vitamin D has attracted attention beyond its classical role in calcium and bone metabolism. Experimental and clinical evidence suggest that vitamin D possesses neuroprotective, anti-inflammatory, immunomodulatory, and antioxidative properties. Vitamin D receptors are widely distributed in neuronal tissues, Schwann cells, and immune cells, suggesting a potential role in nerve repair and modulation of neuropathic pain pathways.(Liu et al., 2025) Several observational studies have demonstrated a high prevalence of vitamin D deficiency among patients with diabetic neuropathy, and low serum vitamin D levels have been associated with increased neuropathic pain severity and poorer quality of life. However, available interventional studies remain limited and have produced inconsistent findings regarding the therapeutic benefit of vitamin D supplementation in DPN.(Ou et al., 2021) Therefore, this study aims to evaluate whether vitamin D supplementation can improve neuropathic pain, sleep quality, and health-related quality of life among patients with diabetic peripheral neuropathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Serum 25(OH)D < 30 ng/mL 6. Stable antidiabetic treatment for at least 3 months

Disqualifiers

Type 1 diabetes mellitus

Current vitamin D supplementation within the previous 3 months

Severe renal impairment (eGFR < 30 mL/min/1.73m²)

Severe hepatic impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D

    Dietary supplement

    VITAMIN D SUPPLEMENT

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: controlNo intervention 0 interventions
Group B: testActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome Change in neuropathic pain severity Measured using Visual Analog Scale (Baseline -Week 6 -Week 12)

Time frame
3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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