Cholecalciferol on Hemodialysis Patients

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemodialysis Complication; Vitamin D Deficiency; Vascular Calcification

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT03602430

phCL 36

Details and patient eligibility

About

• 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Drug Group

Experimental group

Description:

twenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period

Treatment:

Drug: Cholecalciferol

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo