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

Creighton University

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Conditions

Vitamin D Deficiency

Interventions

cholecalciferolDIETARY_SUPPLEMENT

a single dose of 2500 micrograms of cholecalciferol

25(OH)DDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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"

Locations (1)

Creighton University

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Serum 25(OH)D response

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

Time frame: 28 days

Data from ClinicalTrials.gov

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