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Comparison of the high dose and conventional regimen of vitamin D effect on antioxidant markers of patients with diabetic foot ulcer

Comparison of the high dose and conventional regimen of vitamin D effect on antioxidant markers of patients with diabetic foot ulcer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241215064055N1
Enrollment
50
Registered
2024-12-20
Start date
2025-01-04
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

diabetic foot ulcer. Type 2 diabetes mellitus with foot ulcer

Interventions

Intervention 1: Intervention group: First (Recipients of three doses of 50,000 IU vitamin D pearls). Intervention 2: Intervention group: Second (Recipients of a single dose of 300,000 IU vitamin D inj

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: plasma calcium level less than 10 vitamin D level in between 20-30 ng/ml age more than 18 years old Diabetic foot ulcer grade 3 and 4 by wagner classification Obtaining informed consent from patients platelet count more than 100000

Exclusion criteria

Exclusion criteria: Sensitivity to vitamin D products Known diseases associated with hypercalcemia Pregnancy and breastfeeding Primary hyperparathyroidism Patients undergoing treatment with chemotherapy or radiotherapy Use of medications that interfere with wound healing, such as: chronic use of corticosteroids (minimum equivalent dose of 40 mg of prednisone), mycophenolate, cyclosporine, tacrolimus, rituximab. Patients with severe renal failure, GFR less than 30 mL per minute. Platelet count less than 100,000, in the time of intramuscular injection of the ampoule. Hospitalization for diabetic foot ulcers in the past month Administration of injectable antibiotics for diabetic foot ulcers in the past month. Stenosis and severe occlusion of the lower limb vessels based on vascular ultrasound. Chronic alcohol consumption of more than 250 cc daily. Presence of other concurrent disorders or infections.

Design outcomes

Primary

MeasureTime frame
Total Antioxidant Capacity. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory.;Blood Malondialdehyde Level. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory.;Blood Nitric Oxide Level. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory.;Maximum Erythrocyte Sedimentation Rate (ESR) level in Millimeters per Hour. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory.;The highest concentration of C-reactive protein (CRP) in blood is measured in milligrams per liter. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRozita Salehi sadaqiani

Oroumia University of Medical Sciences

www.rozita.salehi@ymail.com+98 44 3343 7522

Outcome results

None listed

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