Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460338
• Other study ID #: PhCl37
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 15, 2022
• Est. completion date: January 26, 2023

Study information

• Verified date: February 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 26, 2023
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Oxidative Stress
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
native form of Vitamin D.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(25(OH)D)	Change in serum 25-hydroxy vitamin D (25(OH)D) level	3 months
Secondary	serum sodium dismutase (SOD)	Change in serum sodium dismutase (SOD) levels	3 months
Secondary	intact parathyroid hormone (iPTH)	Change in intact parathyroid hormone (iPTH) level	3 months
Secondary	serum Malondialdehyde (MDA)	Change in serum Malondialdehyde (MDA) level	3 months
Secondary	serum high sensitive C-reactive Protein (HsCRP)	Change in serum high sensitive C-reactive Protein (HsCRP) level	3 months
Secondary	serum calcium level (Ca)	Change of serum calcium level (Ca),	3 months
Secondary	serum phosphate level (PO4)	Change of serum phosphate level (PO4).	3 months