Abstract
INTRODUCTION
There is a great interest in vitamin-D supplementation that has recently grown; as the scientific community has reported extra renal production of calcitriol by cells in nearly all body systems and the presence of vitamin-D binding receptors in different tissues5 as the 1-α hydroxylase enzyme has been found in parts of the body outside the kidney1.
A recent study in hemodialysis patients showed that 1,25-dihydroxvitamin-D3 levels increased after supplementation with nutritional vitamin-D, suggesting that even in ESRD there is enough extra renal 1-α hydroxylase activity to influence serum levels there by showing a role for nutritional vitamin D in patients with kidney disease6
OBJECTIVES
1. To find the effect of oral cholecalciferol supplementation on Bone Mineral Metabolism (25 hydroxyvitamin D level, Alkaline Phosphatase, intact Parathyroid Hormone (iPTH), Calcium (Ca), Phosphorus (P), calcium phosphorus product(Ca x P)) and
2. To find the effects of its supplementation on marker of inflammation (C Reactive Protein, White blood cell count) and chronic musculoskeletal symptoms (visual analog scale).
MATERIAL AND METHODS:
Study Design:
Double blind Randomized controlled trail.
Settings:
The study will be carried out in the Hemodialysis Unit, Shaikh Zayad Hospital Lahore.
Duration of Study:
2 months.
SAMPLE SIZE: 70 , 35 in each group
The sample size of 35 was estimated by using 95% confidence level, 90% power of the test with expected iPTH level at baseline and at two months 295± 90 and 249± 80 respectively24.
SAMPLING TECHNIQUE:
Lottery method
SAMPLE SELECTION:
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 1 month prior to enrollment during the study
Any diagnosed malignancy, tubercular infection, sarcoidosis, pregnancy
Calcitriol or activated 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
OUTCOME VARIABLES
Serum level of 25 hydroxyvitamin D level, Alkaline Phosphatase, intact Parathyroid Hormone (iPTH), Calcium (Ca), Phosphorus (P), calcium phosphorus product(Ca x P)C Reactive Protein, White blood cell count) and
for Chronic musculoskeletal symptoms (visual analog scale).