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Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease

Primary Purpose

Chronic Kidney Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Diseases

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • likely be able to complete the study, >3 months on hemodialysis, receiving standard of care through their nephrologist.

Exclusion Criteria:

  • on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that interfere with vitamin D absorption, taking vitamin D >800 IU per day, 25(OH)D level >30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Vitamin D 4000

    Vitamin D 2400

    Arm Description

    At baseline, if subjects 25(OH)D levels are 12-19.9, they will be started on 4000 IU per day.

    At baseline, if subjects 25(OH)D levels are 20-30, they will be started on 2400 IU per day.

    Outcomes

    Primary Outcome Measures

    25(OH)D level
    25(OH)D level

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2019
    Last Updated
    August 12, 2023
    Sponsor
    University of Nebraska
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04167111
    Brief Title
    Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease
    Official Title
    Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Covid pandemic
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    May 6, 2021 (Actual)
    Study Completion Date
    May 6, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska

    4. Oversight

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

    5. Study Description

    Brief Summary
    Feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin D level of 35-50 ng/ml in end stage renal disease patients
    Detailed Description
    Pilot study to test the feasibility of adjusting doses based on a prespecified algorithm to reach a 6 month 25(OH)D level of 35-50 ng/ml in end stage renal disease patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Subjects will be started on Vitamin D3 4000 per day or 2400 IU per day at baseline and based on 3 month 25(OH)D levels, will be adjusted to a different vitamin D dose if needed
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D 4000
    Arm Type
    Active Comparator
    Arm Description
    At baseline, if subjects 25(OH)D levels are 12-19.9, they will be started on 4000 IU per day.
    Arm Title
    Vitamin D 2400
    Arm Type
    Active Comparator
    Arm Description
    At baseline, if subjects 25(OH)D levels are 20-30, they will be started on 2400 IU per day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Cholecalciferol
    Other Intervention Name(s)
    Vitamin D3
    Intervention Description
    Vitamin D
    Primary Outcome Measure Information:
    Title
    25(OH)D level
    Description
    25(OH)D level
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: likely be able to complete the study, >3 months on hemodialysis, receiving standard of care through their nephrologist. Exclusion Criteria: on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that interfere with vitamin D absorption, taking vitamin D >800 IU per day, 25(OH)D level >30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura Graeff-Armas, MD, MS, PhD
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease

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