Cholecalciferol on Hemodialysis Patients

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-09-28

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Hemodialysis Complication Vitamin D Deficiency Vascular Calcification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

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

Placebo Group

twenty-five patients will receive a placebo ampule with their standard treatment for 3 months period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Cholecalciferol

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Native vitamin D

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No