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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04167111

Enrollment

Registered

2019-11-18

Start date

2021-05-06

Completion date

2021-05-06

Last updated

2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

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.

Interventions

DIETARY_SUPPLEMENTCholecalciferol

Vitamin D

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
25(OH)D level	6 months	25(OH)D level

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026