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

The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01633658

Enrollment

Registered

2012-07-04

Start date

2012-11-30

Completion date

2013-11-30

Last updated

2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

vitamin D

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.

Detailed description

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

Interventions

DIETARY_SUPPLEMENTcholecalciferol

a single dose of 2500 micrograms of cholecalciferol

DIETARY_SUPPLEMENT25(OH)D

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Serum 25(OH)D response	28 days	25(OH)D will be measured at frequent time intervals over 28 days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026