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

University of Nebraska

Status: Withdrawn

Conditions: Chronic Kidney Diseases

Treatments: Dietary Supplement: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT04167111

0646-19-FB

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 21 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Vitamin D 4000

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol

Vitamin D 2400

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol