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OpenTrials
Completed

NCT Number: NCT05460338

Vitamin D, 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

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Key information

Conditions

Oxidative Stress Avitaminosis Deficiency Diseases Inflammation Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vitamin D Deficiency

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cholecalciferol

Drug

native form of Vitamin D.

Primary outcomes

  1. (25(OH)D)

    Time frame: 3 months

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

Secondary outcomes

  1. serum sodium dismutase (SOD)

    Time frame: 3 months

    Change in serum sodium dismutase (SOD) levels

  2. intact parathyroid hormone (iPTH)

    Time frame: 3 months

    Change in intact parathyroid hormone (iPTH) level

  3. serum Malondialdehyde (MDA)

    Time frame: 3 months

    Change in serum Malondialdehyde (MDA) level

  4. serum high sensitive C-reactive Protein (HsCRP)

    Time frame: 3 months

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

  5. serum calcium level (Ca)

    Time frame: 3 months

    Change of serum calcium level (Ca),

  6. serum phosphate level (PO4)

    Time frame: 3 months

    Change of serum phosphate level (PO4).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 15, 2022
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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