Cholecalciferol on Hemodialysis Patients

January 8, 2019 updated by: Mona AlShahawey AlSayed Ghazy, Ain Shams University

Effect of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Drug Group
twenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period
Drug: Cholecalciferol
Native vitamin D dose of 200IU to be given once per month to hemodialysis patients
Other Names:
  • Native vitamin D
PLACEBO_COMPARATOR: Placebo Group
twenty-five patients will receive a placebo ampule with their standard treatment for 3 months period.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D level
Time Frame: 3 months
Target serum Vitamin D level ≥ 30 ng/ml
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2018

Primary Completion (ACTUAL)

September 15, 2018

Study Completion (ACTUAL)

September 28, 2018

Study Registration Dates

First Submitted

July 1, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (ACTUAL)

July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • phCL 36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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