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

August 29, 2024 updated by: University of Nebraska
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-4130
        • University of Nebraska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D 4000
At baseline, if subjects 25(OH)D levels are 12-19.9, they will be started on 4000 IU per day.
Dietary supplement: Cholecalciferol
Vitamin D
Other Names:
  • Vitamin D3
Active Comparator: Vitamin D 2400
At baseline, if subjects 25(OH)D levels are 20-30, they will be started on 2400 IU per day.
Dietary supplement: Cholecalciferol
Vitamin D
Other Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25(OH)D level
Time Frame: 6 months
25(OH)D level
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Laura Graeff-Armas, MD, MS, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

May 6, 2021

Study Completion (Actual)

May 6, 2021

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0646-19-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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