Inflammation, Oxidative Stress, Vitamin D Deficiency
Conditions
Brief summary
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
Interventions
DRUGCholecalciferol
native form of Vitamin D.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (25(OH)D) | 3 months | Change in serum 25-hydroxy vitamin D (25(OH)D) level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intact parathyroid hormone (iPTH) | 3 months | Change in intact parathyroid hormone (iPTH) level |
| serum Malondialdehyde (MDA) | 3 months | Change in serum Malondialdehyde (MDA) level |
| serum sodium dismutase (SOD) | 3 months | Change in serum sodium dismutase (SOD) levels |
| serum calcium level (Ca) | 3 months | Change of serum calcium level (Ca), |
| serum phosphate level (PO4) | 3 months | Change of serum phosphate level (PO4). |
| serum high sensitive C-reactive Protein (HsCRP) | 3 months | Change in serum high sensitive C-reactive Protein (HsCRP) level |
Countries
Egypt
Outcome results
None listed