Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

Phase 2

Completed

• Conditions: Inflammation; Oxidative Stress; Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT05460338
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-15
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-15
• Primary Completion: 2022-09-15
• Study Completion: 2023-01-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly Cholecalciferol Group	Cholecalciferol	25 hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, taken post-hemodialysis session for 3 months.
Monthly Cholecalciferol Group	Cholecalciferol	25 hemodialysis patients on Oral 200.000IU Cholecalciferol, once monthly, for 3 months.

Primary Outcome Measures

Name	Time	Method
(25(OH)D)	3 months	Change in serum 25-hydroxy vitamin D (25(OH)D) level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt