Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oslo
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Fish oil capsule
Intervention: Fish oil capsule (specially manufactured for the study) (Dietary Supplement)
Multivitamin tablet
Intervention: Multivitamin tablet of type: Vitaplex ABCD (Dietary Supplement)
Outcomes
Primary Outcomes
Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups
Time Frame: 4 weeks (28 days) between baseline and follow-up visit
Secondary Outcomes
- 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)
Investigators
Haakon E. Meyer
Professor
University of Oslo