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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04167111
Other study ID # 0646-19-FB
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date May 6, 2021

Study information

Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 6, 2021
Est. primary completion date May 6, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
Cholecalciferol
Vitamin D

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Outcome

Type Measure Description Time frame Safety issue
Primary 25(OH)D level 25(OH)D level 6 months
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