Cholecalciferol on Hemodialysis Patients

NCT03602430 | Completed Phase 2

• 1 other identifier: phCL 36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Vitamin D Deficiency; Vascular Calcification

Outcome Measures

Primary Outcomes (1)

• Vitamin D level

  Target serum Vitamin D level ≥ 30 ng/ml

  3 months

Study Arms (2)

Drug Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cholecalciferol DRUG

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

Also known as: Native vitamin D

Drug Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

Related Publications (1)

• Alshahawey M, El Borolossy R, El Wakeel L, Elsaid T, Sabri NA. The impact of cholecalciferol on markers of vascular calcification in hemodialysis patients: A randomized placebo controlled study. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):626-633. doi: 10.1016/j.numecd.2020.09.014. Epub 2020 Sep 21.

  PMID: 33594986 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Vascular Calcification

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 28, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)