NCT02876822

Brief Summary

The purpose of this study is to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

August 26, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 19, 2016

Last Update Submit

August 18, 2020

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Serum 25OHD level

    Weekly for 8 weeks

Study Arms (1)

Vitamin D

EXPERIMENTAL

Enrolled subjects will receive one observed oral vitamin D dose (based on current vitamin D status and rounded to the nearest 5000IU) within 2 weeks prior to their HSCT.

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT
Also known as: cholecalciferol
Vitamin D

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Step 1: Patients who are preparing for HSCT, 25OHD level (\<50 ng/mL), and no prior history of HSCT.
  • Step 2: Patients who are preparing for HSCT 25OHD level (\<50 ng/mL).

You may not qualify if:

  • Patients with history of pathologic fractures,
  • uncorrected hypocalcemia or hypophosphatemia,
  • known history of nephrocalcinosis or nephrolithiasis,
  • current granulomatous disease,
  • those currently in ICU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Jonathan Howell, MD

    Cincinnati Children's Hosptial Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 24, 2016

Study Start

August 26, 2016

Primary Completion

March 16, 2017

Study Completion

May 1, 2017

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)