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A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients

Primary Purpose

Vitamin D Deficiency, End Stage Renal Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ergocalciferol supplementation
dialysis techniques
sunlight exposure time
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring vitamin D insufficiency, dialysis, ergocalciferol

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18 years
  • on maintenance dialysis (hemodialysis or peritoneal dialysis) > 3 months
  • 25(OH)D < 30 ng/ml
  • able to provide inform consent form

Exclusion Criteria:

  • current ergocalciferol or cholecalciferol treatment
  • known allergy to ergocalciferol
  • active inflammation or infection
  • advanced stage of cancer
  • pregnancy
  • lactation
  • on immunosuppressive drugs or corticosteroids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Vitamin D supplementation using titration regimen

    Vitamin D supplementation using fixed dose regimen

    Arm Description

    Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described serum 25(OH)D < 5 ng/ml --> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months serum 25(OH)D 5-15 ng/ml--> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months serum 25(OH)D 16-30 ng/ml--> receive ergocalciferol 50,000 IU monthly for 6 months

    Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.

    Outcomes

    Primary Outcome Measures

    proportion of patients with vitamin D adequacy
    serum 25(OH)D more than 30 ng/ml

    Secondary Outcome Measures

    serum calcium
    pre-dialysis serum calcium levels
    serum phosphorus
    pre-dialysis serum phosphorus levels
    serum intact parathyroid hormone
    pre-dialysis serum intact parathyroid hormone levels
    muscle mass
    bioimpedance-derived muscle mass measurement
    muscle strength
    handgrip strength measurement

    Full Information

    First Posted
    June 21, 2022
    Last Updated
    June 26, 2022
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05434377
    Brief Title
    A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients
    Official Title
    A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.
    Detailed Description
    The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, End Stage Renal Disease
    Keywords
    vitamin D insufficiency, dialysis, ergocalciferol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D supplementation using titration regimen
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described serum 25(OH)D < 5 ng/ml --> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months serum 25(OH)D 5-15 ng/ml--> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months serum 25(OH)D 16-30 ng/ml--> receive ergocalciferol 50,000 IU monthly for 6 months
    Arm Title
    Vitamin D supplementation using fixed dose regimen
    Arm Type
    Experimental
    Arm Description
    Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.
    Intervention Type
    Other
    Intervention Name(s)
    ergocalciferol supplementation
    Other Intervention Name(s)
    nutritional vitamin D supplementation
    Intervention Description
    Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
    Intervention Type
    Other
    Intervention Name(s)
    dialysis techniques
    Other Intervention Name(s)
    mode of dialysis
    Intervention Description
    Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
    Intervention Type
    Other
    Intervention Name(s)
    sunlight exposure time
    Intervention Description
    Both groups will be advised to receive similar hours of daily sunlight exposure time.
    Primary Outcome Measure Information:
    Title
    proportion of patients with vitamin D adequacy
    Description
    serum 25(OH)D more than 30 ng/ml
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    serum calcium
    Description
    pre-dialysis serum calcium levels
    Time Frame
    6 months
    Title
    serum phosphorus
    Description
    pre-dialysis serum phosphorus levels
    Time Frame
    6 months
    Title
    serum intact parathyroid hormone
    Description
    pre-dialysis serum intact parathyroid hormone levels
    Time Frame
    6 months
    Title
    muscle mass
    Description
    bioimpedance-derived muscle mass measurement
    Time Frame
    6 months
    Title
    muscle strength
    Description
    handgrip strength measurement
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age > 18 years on maintenance dialysis (hemodialysis or peritoneal dialysis) > 3 months 25(OH)D < 30 ng/ml able to provide inform consent form Exclusion Criteria: current ergocalciferol or cholecalciferol treatment known allergy to ergocalciferol active inflammation or infection advanced stage of cancer pregnancy lactation on immunosuppressive drugs or corticosteroids
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Saranchana Jiampochman
    Phone
    662-256-4000
    Ext
    80801
    Email
    meansaran.@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kamonchanok Metta
    Phone
    662-256-4000
    Email
    kamonchanok.met@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Piyawan Kittiskulnam
    Organizational Affiliation
    Chulalongkorn University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients

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