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

NCT04167111 | Withdrawn

• 1 other identifier: 0646-19-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 25(OH)D level

  25(OH)D level

  6 months

Study Arms (2)

Vitamin D 4000

ACTIVE COMPARATOR

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 2400

ACTIVE COMPARATOR

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

Dietary Supplement: Cholecalciferol

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

Vitamin D

Also known as: Vitamin D3

Vitamin D 2400; Vitamin D 4000

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• likely be able to complete the study, \>3 months on hemodialysis, receiving standard of care through their nephrologist.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Laura Graeff-Armas, MD, MS, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: May 6, 2021
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share