NCT03403647

Brief Summary

Vitamin D is part of the regular treatment regimen among patients after heart transplantation. Due to potential drug-drug interaction between vitamin D and everolmus, these patients are in increased risk for increased everolimus metabolism, potentially leading to under- immunosupression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

January 11, 2018

Last Update Submit

April 17, 2019

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Oral daily everolimus dose change

    8 weeks

Study Arms (2)

Vitamin D deficient

EXPERIMENTAL

Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments

Dietary Supplement: Vitamin D

No vitamin D deficiency

NO INTERVENTION

Regular and routine monitoring

Interventions

Vitamin DDIETARY_SUPPLEMENT

Oral daily vitamin D

Vitamin D deficient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart transplanted patients treated with everolimus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician in the institute for clinical pharmacology

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

July 15, 2018

Primary Completion

April 10, 2019

Study Completion

April 10, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

IL(1)