Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

• Sponsor: Ain Shams University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05460338
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.1
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress; Inflammation; Vitamin D Deficiency	Drug: Cholecalciferol	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Effect of Oral Vitamin D on Oxidative Stress and Inflammation in Hemodialysis
• Actual Study Start Date: Dec 29, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. (25(OH)D) [3 months]

   Change in serum 25-hydroxy vitamin D (25(OH)D) level

Secondary Outcome Measures

1. serum sodium dismutase (SOD) [3 months]

   Change in serum sodium dismutase (SOD) levels

2. intact parathyroid hormone (iPTH) [3 months]

   Change in intact parathyroid hormone (iPTH) level

3. serum Malondialdehyde (MDA) [3 months]

   Change in serum Malondialdehyde (MDA) level

4. serum high sensitive C-reactive Protein (HsCRP) [3 months]

   Change in serum high sensitive C-reactive Protein (HsCRP) level

5. serum calcium level (Ca) [3 months]

   Change of serum calcium level (Ca),

6. serum phosphate level (PO4) [3 months]

   Change of serum phosphate level (PO4).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mona AlShahawey Ghazy, PhD, Assistant professor of Clinical Pharmacy, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05460338
• Other Study ID Numbers: PhCl37
• First Posted: Jul 15, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vitamin D Deficiency; Inflammation; Cholecalciferol; Vitamin D

Study Results

No Results Posted as of Jul 19, 2022