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High-Dose Vitamin D3 for Diabetic Foot Ulcer Healing: Randomized Controlled Trial

NCT07139964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-24

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of high-dose vitamin D3 supplementation in improving diabetic foot ulcer (DFU) healing. DFUs are common, serious complications of diabetes, often associated with delayed wound healing due to persistent inflammation, impaired angiogenesis, and imbalances between matrix metalloproteinase-9 (MMP-9) and its tissue inhibitor (TIMP-1). Vitamin D deficiency is prevalent among DFU patients and is linked to impaired fibroblast function, poor angiogenesis, and increased inflammation.

Participants with DFUs and serum vitamin D levels \<30 ng/mL will be randomized to receive either 10,000 IU oral vitamin D3 daily or placebo for 28 days, in addition to standard DFU care. Primary outcomes include changes in tissue MMP-9/TIMP-1 expression ratio and wound healing progression. The study will provide evidence on whether high-dose vitamin D3 can serve as a safe, effective adjunctive therapy in DFU management.

Conditions

  • Diabetic Foot Ulcer
  • Vitamin D Deficiency
  • Wound Healing Disorder

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Participants receive oral vitamin D3 (cholecalciferol) 10,000 IU daily for 28 consecutive days, in addition to standard diabetic foot ulcer care according to hospital protocols. Vitamin D3 is provided in identical-appearing capsules. Compliance is monitored using the MMAS-8 adherence scale.

OTHER

Placebo

Participants receive an oral placebo capsule daily for 28 consecutive days, in addition to standard diabetic foot ulcer care according to hospital protocols. The placebo is identical in appearance to the vitamin D3 capsule. Compliance is monitored using the MMAS-8 adherence scale.

Sponsors & Collaborators

  • Universitas Sriwijaya

    lead OTHER

Principal Investigators

  • Kemas M Dahlan, M.D. · Consultant Vascular Surgeon, Department of Surgery, Dr. Mohammad Hoesin General Hospital Palembang

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-01-31
Completion
2025-07-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07139964 on ClinicalTrials.gov