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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2021-05-06

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vitamin D 4000

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Vitamin D 2400

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Interventions

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Cholecalciferol

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin D3

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No