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Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

Primary Purpose

Oxidative Stress, Inflammation, Vitamin D Deficiency

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oxidative Stress

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Weekly Cholecalciferol Group

Monthly Cholecalciferol Group

Arm Description

25 hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, taken post-hemodialysis session for 3 months.

25 hemodialysis patients on Oral 200.000IU Cholecalciferol, once monthly, for 3 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2022
Last Updated
February 2, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05460338
Brief Title
Vitamin D, Oxidative Stress and Inflammation in Hemodialysis
Official Title
Effect of Oral Vitamin D on Oxidative Stress and Inflammation in Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
January 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weekly Cholecalciferol Group
Arm Type
Active Comparator
Arm Description
25 hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, taken post-hemodialysis session for 3 months.
Arm Title
Monthly Cholecalciferol Group
Arm Type
Active Comparator
Arm Description
25 hemodialysis patients on Oral 200.000IU Cholecalciferol, once monthly, for 3 months.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
native form of Vitamin D.
Primary Outcome Measure Information:
Title
(25(OH)D)
Description
Change in serum 25-hydroxy vitamin D (25(OH)D) level
Time Frame
3 months
Secondary Outcome Measure Information:
Title
serum sodium dismutase (SOD)
Description
Change in serum sodium dismutase (SOD) levels
Time Frame
3 months
Title
intact parathyroid hormone (iPTH)
Description
Change in intact parathyroid hormone (iPTH) level
Time Frame
3 months
Title
serum Malondialdehyde (MDA)
Description
Change in serum Malondialdehyde (MDA) level
Time Frame
3 months
Title
serum high sensitive C-reactive Protein (HsCRP)
Description
Change in serum high sensitive C-reactive Protein (HsCRP) level
Time Frame
3 months
Title
serum calcium level (Ca)
Description
Change of serum calcium level (Ca),
Time Frame
3 months
Title
serum phosphate level (PO4)
Description
Change of serum phosphate level (PO4).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

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