Cholecalciferol on Hemodialysis Patients

* Screening the prevalence of vitamin D deficiency among Egyptian hemodialysis patients on a single center (Ain Shams University hospital). * Assessing the effect of the native type of vitamin D (Cholecalciferol) on replenishing its deficiency via extra-renal vitamin D receptors (VDR), among Egyptian hemodialysis patients. * Assessing the effect of cholecalciferol on vascular calcification among Egyptian hemodialysis patients. * Assessing the effect of cholecalciferol on Blood pressure, parathyroid hormone.

Completed

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Key information

Conditions

Hemodialysis Complication Avitaminosis Calcinosis Calcium Metabolism Disorders Deficiency Diseases Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vascular Calcification Vitamin D Deficiency

Age range

18 year–75 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

Both sexes aged between 18-75 years
Patients on HD greater than 3 months at least.
Stable clinical condition (no hospitalization in the previous 3 months)
Informed consent in accordance with the Declaration of Helsinki.
PTH level between 150 - 800 pg/ml.

Exclusion criteria

Hypersensitivity to cholecalciferol.
Participant in an another clinical trial within the past 4 weeks.
Judged to be unsuitable as a subject by the attending physician.
Pregnant or breastfeeding female

Treatment and study plan

Cholecalciferol

Drug

Native vitamin D dose of 200IU to be given once per month to hemodialysis patients

Other names: Native vitamin D

Placebo

Drug

A Placebo ampule will be given to hemodialysis patients once per month with their standard treatment for 3 months period. Same color, odor and size, only without the active constituent.

Primary outcomes

Vitamin D level

Time frame: 3 months

Target serum Vitamin D level ≥ 30 ng/ml

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Cholecalciferol on Hemodialysis Patients

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jul 26, 2018
Registry last updated: Jan 9, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed