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IRCT201510315623N54 IRCT 2015-11-04 Kashan University of Medical Sciences 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 2015-11-01 anticipated 60 Complete https://irct.ir/trial/6084 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 2 Diabetic foot. 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
address Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5562 0608 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic foot ulcer Aged 40 to 85 years 40 years 85 years Both 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 E14.5 With peripheral circulatory complications Treatment - Drugs Treatment - Drugs Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks for 12 weeks orally. Control group: Placebo capsule, every week for 12 weeks orally. 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). 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. Kashan University of Medical Sciences Approved 2015-10-28 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences Kashan Isfehan Iran (Islamic Republic of)