Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Level in Vitamin D3 Deficient COPD Patients

On the first day of enrollment, the objectives, nature, purpose and potential risk of all the procedures which are intended to be used for the study will be explained in detail to each COPD patients (diagnosed by pulmonologist), with a cordial attitude giving emphasis on the benefits he might obtain from this study. He will be encouraged for voluntary participation and will be allowed to withdraw himself from the study even after participation, whenever he feels uneasy. If he will agree to be enrolled in the study, an informed written consent will be taken in a prescribed form. Details family history, medical history and thorough physical examination of each patient will be done and all the information will be recorded in a standard data sheet. Then all the patients will be requested to attend the Department of Physiology at 8:30 am (after overnight fasting) on the examination day.

On that day, 16 ml of venous blood will be collected from antecubital vein of patient in different vacutainer tubes and will be taken to the laboratory of Department of Biochemistry and Molecular Biology as soon as possible, where 3 ml will be used for the estimation of serum vitamin D3 and rest will be preserved at -4˚C.

If the patient is with serum 25(OH)D <30 ng/ml (D3 deficiency) but >10 ng/ml (severe D3 deficient; for ethical purpose), then the serum parathormone (PTH), serum calcium, serum inorganic phosphate, serum alkaline phosphatase (ALP), serum glutamate-pyruvate transaminase (SGPT), fasting blood glucose, serum glycosylated hemoglobin HbA1C, serum cholesterol, serum high density lipoprotein (HDL), serum low density lipoprotein (LDL), serum triglyceride (TG), serum creatinine will be assessed from the preserved blood. After getting all the biochemical reports the final selection will be done, according to the inclusion and exclusion criteria. In addition serum level of Catalase and Superoxide dismutase will be done in the Department of Physiology, BSMMU. Then all the eligible patients will be randomly assigned to either 'study (A)' or 'control (B)' group. These data will be recorded as values of 'day 0' (A0, B0).

Subsequently a standard therapeutic treatment (according to Global initiative for chronic obstructive pulmonary disease guideline) will be prescribed (by the pulmonologist) to all the selected stable COPD patients of both groups. Proper education will be given about drug, method of taking medication and medication plan.

Along with the standard pharmacological treatment of COPD, all patients of both the groups will be advised to have sunlight exposure (within 11 am to 2 pm) only for 20 minutes daily and also to continue ad lib (according to their own choice) diet. In addition, oral vitamin D3 (80,000 IU per week) and placebo will be added to the treatment schedule of the 'Study' patients and 'Control' patients, respectively, for consecutive 13 weeks.