NCT01633658

Brief Summary

The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

July 2, 2012

Last Update Submit

May 27, 2013

Conditions

Vitamin D Deficiency

Keywords

vitamin D

Outcome Measures

Primary Outcomes (1)

  • Serum 25(OH)D response

    25(OH)D will be measured at frequent time intervals over 28 days.

    28 days

Study Arms (2)

Vitamin D Cholecalciferol

ACTIVE COMPARATOR

A single dose of 2500 micrograms cholecalciferol

Dietary Supplement: cholecalciferol

25(OH)D

EXPERIMENTAL

A single dose of 625 micrograms 25(OH)D

Dietary Supplement: 25(OH)D

Interventions

cholecalciferolDIETARY_SUPPLEMENT

a single dose of 2500 micrograms of cholecalciferol

Vitamin D Cholecalciferol
25(OH)DDIETARY_SUPPLEMENT

a single dose of 625 micrograms of 25(OH)D

25(OH)D

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ten men and women in each group,
  • aged 20-60.

You may not qualify if:

  • History of hypercalcemia,
  • vitamin D supplement use \> 800 IU daily,
  • BMI \> 30,
  • gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
  • use of steroids in any form,
  • anticonvulsants,
  • antibiotics,
  • acute illness, or
  • vacation planned to "sunny climate"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Laura Armas, MD,MS

    Creighton University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 4, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

US(1)