Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Fish oil capsule (specially manufactured for the study)

• Registration Number: NCT01482689
• Lead Sponsor: University of Oslo

Brief Summary

The main aim of the present study is to compare the bioavailability of vitamin D from cod liver oil and multivitamin tablets given to healthy individuals under the same conditions, as well as to study the influence of gender and ethnicity on vitamin D absorption. Healthy subjects will be randomised into two parallel groups receiving 10 micrograms (400 IU) per day of vitamin D3 from one fish oil capsule or one solid multivitamin tablet, respectively. Serum samples will be drawn at baseline and after four weeks (28 days) for the analysis of 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone, and tartrate resistant acid phosphatase in serum.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2011-11
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Study First Posted: 2011-11-30
• Last Update Posted: 2011-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Must be able to meet at baseline and follow-up visit

Exclusion Criteria

• Using any vitamin D containing supplements regularly (> once per week)
• Travelled to sunny countries in the previous 3 months
• Used a tanning bed in the previous 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil capsule	Fish oil capsule (specially manufactured for the study)	-

Primary Outcome Measures

Name	Time	Method
Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups	4 weeks (28 days) between baseline and follow-up visit

Secondary Outcome Measures

Name	Time	Method
Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups	4 weeks (28 days) between baseline and follow-up visit
Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum intact parathyroid hormone (pmol/l)	4 weeks (28 days) between baseline and follow-up visit
Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum osteoclast-specific tartrate-resistant acid phosphatase (TRACP 5b); U/l	4 weeks (28 days) between baseline and follow-up visit
Difference in delta 25-hydroxyvitamin D (nmol/l) between men and women	4 weeks (28 days) between baseline and follow-up visit
Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum 1,25-dihydroxyvitamin D (pmol/l)	4 weeks (28 days) between baseline and follow-up visit

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway