Overview

Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

Status:
Active, not recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ain Shams University
Treatments:
Cholecalciferol
Vitamin D
Criteria
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.