Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

Study Overview
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Brief Summary
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Vitamin D deficiency is now considered a global problem in general population, but it seemed to be more prominent in chronic kidney disease (CKD) patients, especially those on regular hemodialysis. Being a key regulator in mineral metabolism, there's also emerging evidences linking vitamin D deficiency with inflammation and oxidative stress, which are both recognized as constant threats to cardiovascular outcomes in hemodialysis patients. It's prospective, randomized trial that's carried out to evaluate the effect of weekly versus, monthly oral cholecalciferol, on vitamin D (25(OH)D) levels, oxidative stress markers, inflammatory markers and secondary hyperparathyroidism in hemodialysis patients. Fifty eligible hemodialysis patients were randomly assigned to either Group A (Oral 50.000IU Cholecalciferol, once weekly) or Group B (Oral 200.000IU Cholecalciferol, once monthly), for 3 months. Serum levels of (25(OH)D), serum malondialdehyde (MDA), serum superoxide dismutase (SOD), serum high sensitive (hsCRP), calcium, phosphorus, and intact parathormone (iPTH) levels, were all assessed at baseline and at the end of the study

Official Title
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Effect of Oral Vitamin D on Oxidative Stress and Inflammation in Hemodialysis

Conditions
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Oxidative Stress, Inflammation, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged between 18-70 years, on maintenance hemodialysis for a duration of 3 months or more, in a stable clinical condition (no hospitalization in the previous 3 months), with serum vitamin D levels of < 30 ng/ml. Exclusion Criteria: Patients with hypersensitivity to cholecalciferol, ongoing cholecalciferol therapy, liver failure, digestive malabsorption disease, being participating in an another clinical trial within the past 4 weeks, females that are pregnant or breastfeeding, or patients being judged to be unsuitable to be enrolled by the attending physician.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly Cholecalciferol Group<br>25 hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, taken post-hemodialysis session for 3 months. | Drug: Cholecalciferol<br>* native form of Vitamin D.<br>|
| Active Comparator: Monthly Cholecalciferol Group<br>25 hemodialysis patients on Oral 200.000IU Cholecalciferol, once monthly, for 3 months. | Drug: Cholecalciferol<br>* native form of Vitamin D.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (25(OH)D) | Change in serum 25-hydroxy vitamin D (25(OH)D) level | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum sodium dismutase (SOD) | Change in serum sodium dismutase (SOD) levels | 3 months | 
| intact parathyroid hormone (iPTH) | Change in intact parathyroid hormone (iPTH) level | 3 months | 
| serum Malondialdehyde (MDA) | Change in serum Malondialdehyde (MDA) level | 3 months | 
| serum high sensitive C-reactive Protein (HsCRP) | Change in serum high sensitive C-reactive Protein (HsCRP) level | 3 months | 
| serum calcium level (Ca) | Change of serum calcium level (Ca), | 3 months | 
| serum phosphate level (PO4) | Change of serum phosphate level (PO4). | 3 months |