NCT05460338

Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Oxidative Stress
• Inflammation
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Cholecalciferol	native form of Vitamin D.

Timeline

• Start date: 2022-05-15
• Primary completion: 2022-09-15
• Completion: 2023-01-26
• First posted: 2022-07-15
• Last updated: 2023-02-06

Locations

1 site across 1 country: Egypt