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IRCT2015091323989N1 IRCT 2015-11-09 Nephrology Department, Shaikh Zayad Hospital Effect of Vitamin D (Cholecalciferol) supplementation on bone mineral metabolism in patient on Dialysis ESRD-end stage renal disease Effects of cholecalciferol supplementation on Bone mineral metabolism in end stage renal disease patients in comparison with placebo 2015-11-10 anticipated 70 Complete https://irct.ir/trial/20355 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Group A and Group B will be written in 70 close envelop, 35 each . Hemodialysis staff will take the envelop out by lottery method and allocate the group. 4 End stage renal disease patients on hemodialysis. Intervention 1: Intervention /group A Supplementation with cholecalciferol will be done in 25 hydoxyvitamin D deficiency 35 patients on thrice weekly maintenence hemodialysis patients according to 25-hydroxyvitamin D3 serum levels. 50,000 IU cholecalciferol once a week will be given for patients with 25-hydroxyvitamin D levels <15 ng/ml, 10,000 IU once a week when 25-hydroxyvitamin D3 level between 16 and 30 ng/ml.The supplementation with cholecalciferol capsule, once a week will be given orally, with meal during their hemodialysis session, under supervision by study staff. All the test 25-hydroxyvitamin D3 level, iPTH, alkaline phosphatase, Ca, P, albumin, Complete blood count, and CRP level will be done before intervention and repeated after two months of supplementation. Intervention 2: Control group/Group BSimilar placebo is given to group B patients on thrice weekly maintenance hemodialysis patients according to 25-hydroxyvitamin D levels . The supplementation with placebo, once a week will be given orally, with meal during their hemodialysis session, under supervision by study staff. All the test 25-hydroxyvitamin D3 level, iPTH, alkaline phosphatase, Ca, P, albumin, Complete blood count, and CRP level will be done before the intervention and repeated after two months of supplementation.

public Sumit Acharya

Shaikh Zayad Hospital, Nephrology Department, Khayaban-e-jamia punjab road, Block D New Muslim Town

Lahore Pakistan 92 00924299230727 med-2009-5529@cpsp.pk College of Physician and Surgeon of Pakistan scientific Sumit Acharya

Shaikh Zayad Hospital, Nephrology Department, Khayaban-e-jamia punjab road, Block D New Muslim Town

Lahore Pakistan 0092 00924299230727 sumitacharya2@gmail.com College of Physician and Surgeon of Pakistan Pakistan Inclusion criteria: Age more than 18 years On hemodialysis thrice per week for more than 3 months Both the gender Patients who give informed consents Exclusion criteria: The patients with history of active bleeding (melena, hematemesis, hematochezia). Patients who have taken cholecalceferol or ergocholicalciferol within two months period, Patients taking cinacalcet Iv Iron in 1 month prior to enrollment Blood transfusion 1month prior to enrollment during the study Any diagnosed malignancy, tubercular infection, sarcoidosis, pregnancy Calcitriol or active vitamin D3 or erythropoietin dosage adjustment 1 month prior to enrollment Patients having corrected serum calcium>10.2 mg/dl or having serum phosphorus >6mg/dl 18 years 70 years Both N18.5 End stage kidney disease:on dialysis Treatment - Drugs Placebo Intervention /group A Supplementation with cholecalciferol will be done in 25 hydoxyvitamin D deficiency 35 patients on thrice weekly maintenence hemodialysis patients according to 25-hydroxyvitamin D3 serum levels. 50,000 IU cholecalciferol once a week will be given for patients with 25-hydroxyvitamin D levels <15 ng/ml, 10,000 IU once a week when 25-hydroxyvitamin D3 level between 16 and 30 ng/ml.The supplementation with cholecalciferol capsule, once a week will be given orally, with meal during their hemodialysis session, under supervision by study staff. All the test 25-hydroxyvitamin D3 level, iPTH, alkaline phosphatase, Ca, P, albumin, Complete blood count, and CRP level will be done before intervention and repeated after two months of supplementation. Control group/Group BSimilar placebo is given to group B patients on thrice weekly maintenance hemodialysis patients according to 25-hydroxyvitamin D levels . The supplementation with placebo, once a week will be given orally, with meal during their hemodialysis session, under supervision by study staff. All the test 25-hydroxyvitamin D3 level, iPTH, alkaline phosphatase, Ca, P, albumin, Complete blood count, and CRP level will be done before the intervention and repeated after two months of supplementation. 1. 25 hydroxyvitamin D level. Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: ELISA kit. 2. intact Parathyroid Hormone (iPTH). Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: ELISA kit. 3. Alkaline Phosphatase. Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: Standard chemical analyzer. 4. Calcium (Ca). Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: Standard chemical analyzer. 5. Phosphorus (P). Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: Standard chemical analyzer. 6. calcium phosphorus product(Ca x P). Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: calculated from calcium and phosphorus product. 1. C Reactive Protein. Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: ELISA Kit. 2. Chronic musculoskeletal symptoms. Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: Visual Analog Scale. 3. White blood cell count. Timepoint: At baseline and 2 months after the date of intervention. Method of measurement: Automated counter. Shaikh Zayad Hospital Nephrology Department, Shaikh Zayad Hospital Shaikh Zayad Hospital Approved 2015-02-11 Dr Farkandha, National Health council, Institutional Review Board, IORG0006065, Federal postgraduate National Health Research Complex, Federal Postgraduate Medical Institute, Shaikh Zayad Hospital, Muslim Town Lahore Punjab Pakistan