Hemodialysis Complication, Vascular Calcification, Vitamin D Deficiency
Conditions
Brief summary
* 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.
Interventions
DRUGCholecalciferol
Native vitamin D dose of 200IU to be given once per month to hemodialysis patients
DRUGPlacebo
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D level | 3 months | Target serum Vitamin D level ≥ 30 ng/ml |
Countries
Egypt
Outcome results
None listed