NCT05460338

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

July 13, 2022

Last Update Submit

February 2, 2023

Conditions

Oxidative StressInflammationVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • (25(OH)D)

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

    3 months

Secondary Outcomes (6)

  • serum sodium dismutase (SOD)

    3 months

  • intact parathyroid hormone (iPTH)

    3 months

  • serum Malondialdehyde (MDA)

    3 months

  • serum high sensitive C-reactive Protein (HsCRP)

    3 months

  • serum calcium level (Ca)

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Weekly Cholecalciferol Group

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Monthly Cholecalciferol Group

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

native form of Vitamin D.

Monthly Cholecalciferol GroupWeekly Cholecalciferol Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

InflammationVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Clinical Pharmacy

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 15, 2022

Study Start

May 15, 2022

Primary Completion

September 15, 2022

Study Completion

January 26, 2023

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

EG(1)