Effects of supplementation in the treatment of diabetic foot

Effects of vitamin D supplementation compared with the placebo on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201510315623N54

Enrollment

Registered

2015-11-04

Start date

2015-11-01

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Diabetic foot. With peripheral circulatory complications

Interventions

Intervention 1: Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks for 12 weeks orally. Intervention 2: Control group: Placebo capsule, every week for 12 weeks orally.

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients with diabetic foot ulcer Aged 40 to 85 years

Exclusion criteria

Exclusion criteria: Diabetic foot ulcer with grade 3 Pregnant and breastfeeding patients Participants who consumed vitamin D supplements during the past 3 months Anticipated changes in medications throughout the study Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma

Design outcomes

Primary

Measure	Time frame
Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Healing of diabetic foot ulcer. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm).	—

Secondary

Measure	Time frame
Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Vitamin D. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;HbA1c. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Biochemical kit.;LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Vitamin D. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;HbA1c. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Biochemical kit.;LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5562 0608

Outcome results

None listed

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