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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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Diabetic foot ulcers are a prevalent and serious complication of uncontrolled diabetes, with a significant proportion leading to infection, amputation, and mortality. Delayed wound healing in DFUs is often driven by prolonged inflammation, persistent infection, impaired angiogenesis, and an imbalance between extracellular matrix (ECM) degradation by MMP-9 and inhibition by TIMP-1. Elevated MMP-9 levels disrupt keratinocyte migration, collagen deposition, and epithelial regeneration, while reduced TIMP-1 further compromises healing.

Vitamin D plays a regulatory role in immune modulation, inflammation control, fibroblast activity, and angiogenesis. Observational and interventional studies have shown that vitamin D deficiency is common in DFU patients and is associated with slower healing. Supplementation has been linked to improved wound healing, reduced inflammatory markers, and better microcirculation. Vitamin D may also modulate MMP-9 and TIMP-1 expression, thereby restoring ECM balance.

This study is a double-blind, placebo-controlled, randomized controlled trial conducted at Dr. Mohammad Hoesin General Hospital, Palembang. Eligible participants are adults with DFUs, low serum vitamin D (\<30 ng/mL), and no exclusion criteria such as advanced kidney disease, severe liver disease, osteomyelitis, or sepsis. Participants will be randomized into two groups:

Intervention group: Oral vitamin D3, 10,000 IU daily for 28 days Control group: Placebo daily for 28 days Both groups will receive standard DFU care. Compliance will be monitored with the MMAS-8 scale. Primary outcomes are changes in tissue MMP-9 and TIMP-1 expression (assessed by immunohistochemistry) and wound healing parameters. Secondary outcomes include changes in serum vitamin D levels and correlation between vitamin D status and wound healing outcomes.

The study aims to determine whether high-dose vitamin D3 supplementation reduces the MMP-9/TIMP-1 ratio and accelerates wound healing, potentially supporting its use as a standard adjunctive therapy for DFUs.

Conditions

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Diabetic Foot Ulcer Vitamin D Deficiency Wound Healing Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental: High-dose Vitamin D3

Description: Participants receive oral vitamin D3, 10,000 IU daily for 28 days, plus standard care for diabetic foot ulcers.

Intervention Name: Vitamin D3 (Cholecalciferol) Type: Dietary Supplement Dosage: 10,000 IU daily Duration: 28 days

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo Comparator: Placebo

Description: Participants receive oral placebo daily for 28 days, plus standard care for diabetic foot ulcers.

Intervention Name: Placebo Type: Inactive substance Dosage: Matched placebo daily Duration: 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Other Intervention Names

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Cholecalciferol Inert capsule

Eligibility Criteria

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Inclusion Criteria

Diagnosis of diabetic foot ulcer (DFU) Serum 25-hydroxyvitamin D level \< 30 ng/mL Willingness and ability to provide written informed consent Ability to comply with study procedures and follow-up visits

Exclusion Criteria

Currently undergoing cancer treatment Pregnant or breastfeeding Current use of vitamin D supplementation History of autoimmune disease Chronic kidney disease with estimated GFR \< 30 mL/min/1.73 m² Abnormal liver function tests (AST or ALT ≥ 3× upper normal limit) Ankle-brachial index (ABI) \< 0.4 Presence of osteomyelitis Proven sepsis Allergy to vitamin D3 Amputation prior to randomization Withdrawal of consent during the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No