Vitamin D in Diabetic Neuropathy

Effect of Vitamin D Supplementation on Neuropathic Pain, Sleep Quality, and Quality of Life in Patients With Diabetic Peripheral Neuropathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Nephropathy Type 2
• Intervention / Treatment: Dietary supplement: Vitamin D

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

Participants must fulfill all the following:

1. Age between 18 and 75 years 2. Diagnosed with type 2 diabetes mellitus according to ADA criteria 3. Clinically diagnosed diabetic peripheral neuropathy 4. Neuropathic symptoms for at least 3 months 5. Vitamin D insufficiency or deficiency:

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

  1. Type 1 diabetes mellitus
  2. Current vitamin D supplementation within the previous 3 months
  3. Severe renal impairment (eGFR < 30 mL/min/1.73m²)
  4. Severe hepatic impairment
  5. Hypercalcemia
  6. Malabsorption syndromes
  7. Pregnancy or lactation
  8. Peripheral neuropathy due to causes other than diabetes:
• Vitamin B12 deficiency
• Hypothyroidism
• Alcoholic neuropathy
• Chemotherapy-induced neuropathy 9. Active malignancy 10. Severe psychiatric illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Active Comparator: test	Dietary supplement: Vitamin D; VITAMIN D SUPPLEMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary outcome Change in neuropathic pain severity Measured using Visual Analog Scale (Baseline -Week 6 -Week 12)	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Steroids; Fused-Ring Compounds; Secosteroids; Vitamin D
• Other Study ID Numbers: Vitamin D in DNP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No