Vitamin D as an add on Therapy in the Treatment of Diabetic Peripheral Neuropathy

Effectiveness of Vitamin D as a supplement with Conventional Therapy in the Treatment of Diabetic Peripheral Neuropathy - A Randomized Controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/015983

Enrollment

Registered

2018-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications Health Condition 2: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Cholecalciferol: Dose-60,000 IU Duration-once weekly for 3 months Control Intervention1: Amitriptyline: Dose- 25mg Duration- once daily for 3 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Diabetic peripheral neuropathy 2. Both male and female patients above 18 years. 3. Patients who are willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Hypercalcemia and malabsorption syndrome. 2. Known case of hypothyroidism/hyperthyroidism. 3. Patient currently taking vitamin D supplementation/ antiepileptic or anti tuberculosis medications. 4. Patient with any other significant medical illness which can interfere with study assessments. 5. Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
Improvement in Vitamin D levels, Improvement in Neuropathic Pain using Douleur Neuropathique 4 (DN4) pain diagnostic questionnaires,Neuropathic quality of life using McGill pain score.Timepoint: 0 and end of 12 weeks	—

Secondary

Measure	Time frame
Glycated Hemoglobin (HbA1c)Timepoint: 0 and end of 12 weeks	—

Countries

India

Contacts

Public ContactDr TM Vijayakumar

SRM Medical College Hospital and Research Centre

melvingeorge2003@gmail.com9894133697

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026