Pilot Study- Treat to Target Vitamin D in End Stage Renal... | NCT04167111

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

NCT04167111

Sponsor

University of Nebraska

Status

Withdrawn

Last Update Posted

Sep 3, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Kidney Diseases

Interventions

Cholecalciferol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Covid pandemic

Expanded Access Info

Start Date

May 6, 2021Actual

Primary Completion Date

May 6, 2021Actual

Completion Date

May 6, 2021Actual

First Submitted Date

Nov 14, 2019

First Submission Date that Met QC Criteria

Nov 14, 2019

First Posted Date

Nov 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2024

Last Update Posted Date

Sep 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Dietary Supplement	Vitamin D	Vitamin D 2400 Vitamin D 4000

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Graeff-Armas, MD, MS, PhD	University of Nebraska	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided