Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

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

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

Study Overview

• Status: Completed
• Conditions: Inflammation; Vitamin D Deficiency; Oxidative Stress
• Intervention / Treatment: Drug: Cholecalciferol

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Weekly Cholecalciferol Group; 25 hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, taken post-hemodialysis session for 3 months.	Drug: Cholecalciferol; native form of Vitamin D.
ACTIVE_COMPARATOR: Monthly Cholecalciferol Group; 25 hemodialysis patients on Oral 200.000IU Cholecalciferol, once monthly, for 3 months.	Drug: Cholecalciferol; native form of Vitamin D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(25(OH)D)	Change in serum 25-hydroxy vitamin D (25(OH)D) level	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2022
• Primary Completion (ACTUAL): September 15, 2022
• Study Completion (ACTUAL): January 26, 2023

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (ACTUAL): July 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammation; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: PhCl37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No