Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2023-01-26

Brief Summary

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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

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Detailed Description

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Conditions

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Oxidative Stress Inflammation Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Weekly Cholecalciferol Group

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

native form of Vitamin D.

Monthly Cholecalciferol Group

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

native form of Vitamin D.

Interventions

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Cholecalciferol

native form of Vitamin D.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No