The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitamin D Cholecalciferol

A single dose of 2500 micrograms cholecalciferol

Group Type ACTIVE_COMPARATOR

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

a single dose of 2500 micrograms of cholecalciferol

25(OH)D

A single dose of 625 micrograms 25(OH)D

Group Type EXPERIMENTAL

25(OH)D

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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cholecalciferol

a single dose of 2500 micrograms of cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

25(OH)D

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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"

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes