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

Creighton University

Status: Withdrawn

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: cholecalciferol; Dietary Supplement: 25(OH)D

Study type: Interventional

Funder types: Other

Identifiers

NCT01633658

Creighton 13

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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"

Trial design

0 participants in 2 patient groups

Vitamin D Cholecalciferol

Active Comparator group

Description:

A single dose of 2500 micrograms cholecalciferol

Treatment:

Dietary Supplement: cholecalciferol

25(OH)D

Experimental group

Description:

A single dose of 625 micrograms 25(OH)D

Treatment:

Dietary Supplement: 25(OH)D