Clinical trial NCT01482689: Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
Official title: Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Bioavailability
Vitamin D metabolism
Bone turnover
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: Hormone Laboratory, Aker University Hospital, Oslo, Norway
name: Norwegian Foundation for Health and Rehabilitation
First posted: 2011-11-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups
timeFrame: 4 weeks (28 days) between baseline and follow-up visit
Secondary outcomes:
measure: Difference in delta 25-hydroxyvitamin D (nmol/l) between men and women
timeFrame: 4 weeks (28 days) between baseline and follow-up visit
measure: Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups
timeFrame: 4 weeks (28 days) between baseline and follow-up visit
measure: Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum intact parathyroid hormone (pmol/l)
timeFrame: 4 weeks (28 days) between baseline and follow-up visit
measure: Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum 1,25-dihydroxyvitamin D (pmol/l)
timeFrame: 4 weeks (28 days) between baseline and follow-up visit
measure: Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum osteoclast-specific tartrate-resistant acid phosphatase (TRACP 5b); U/l
timeFrame: 4 weeks (28 days) between baseline and follow-up visit
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References:
citation: Holvik K, Madar AA, Meyer HE, Lofthus CM, Stene LC. A randomised comparison of increase in serum 25-hydroxyvitamin D concentration after 4 weeks of daily oral intake of 10 microg cholecalciferol from multivitamin tablets or fish oil capsules in healthy young adults. Br J Nutr. 2007 Sep;98(3):620-5. doi: 10.1017/S000711450773074X. Epub 2007 Apr 24.
citation: Holvik K, Madar AA, Meyer HE, Lofthus CM, Stene LC. Changes in the vitamin D endocrine system and bone turnover after oral vitamin D3 supplementation in healthy adults: results of a randomised trial. BMC Endocr Disord. 2012 Jun 13;12:7. doi: 10.1186/1472-6823-12-7.