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

This study has been completed.

Sponsor:

Collaborators:

Norwegian Institute of Public Health

Hormone Laboratory, Aker University Hospital, Oslo, Norway

Norwegian Foundation for Health and Rehabilitation

Information provided by (Responsible Party):

Haakon E. Meyer, University of Oslo

ClinicalTrials.gov Identifier:

NCT01482689

First received: November 23, 2011

Last updated: November 28, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 23, 2011
Last Updated Date	November 28, 2011
Start Date ^ICMJE	February 2005
Primary Completion Date	April 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 28, 2011)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01482689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 28, 2011)	Difference in delta 25-hydroxyvitamin D (nmol/l) between men and women [ Time Frame: 4 weeks (28 days) between baseline and follow-up visit ] [ Designated as safety issue: No ] Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups [ Time Frame: 4 weeks (28 days) between baseline and follow-up visit ] [ Designated as safety issue: No ] Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum intact parathyroid hormone (pmol/l) [ Time Frame: 4 weeks (28 days) between baseline and follow-up visit ] [ Designated as safety issue: No ] Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum 1,25-dihydroxyvitamin D (pmol/l) [ Time Frame: 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 [ Time Frame: 4 weeks (28 days) between baseline and follow-up visit ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
Official Title ^ICMJE	Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Dietary Supplement: Fish oil capsule (specially manufactured for the study) One capsule per day for 4 weeks (28 days). The fish oil group receives a daily supplement of one fish oil capsule, specially manufactured for the present study by Peter Möller (now Möller's, Nydalen, Norway). The fish oil capsules are aimed to contain a dose of cholecalciferol identical to the dose already found in the multivitamin tablets by analysis in an independent laboratory (AS Vitas, Oslo, Norway), and similar doses of vitamin A. In addition, the fish oil capsule contains vitamin E and n-3 fatty acids. Dietary Supplement: Multivitamin tablet of type: Vitaplex ABCD One tablet per day for 4 weeks (28 days). The multivitamin group receives a daily supplement of one multivitamin tablet of type Vitaplex ABCD (Cederroth AS, Revetal, Norway), a common vitamin supplement sold in grocery stores in Norway. In addition to 10 micrograms (400 IU) of cholecalciferol,the multivitamin tablet contains vitamin A and the water-soluble vitamins: B1, B2, B6, Niacin, pantothenic acid, and vitamin C. Other Name: Vitaplex ABCD
Study Arm (s)	Experimental: Fish oil capsule Intervention: Dietary Supplement: Fish oil capsule (specially manufactured for the study) Experimental: Multivitamin tablet Intervention: Dietary Supplement: Multivitamin tablet of type: Vitaplex ABCD
Publications *	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. Epub 2007 Apr 24.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	74
Completion Date	April 2005
Primary Completion Date	April 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01482689
Other Study ID Numbers ^ICMJE	S-04340
Has Data Monitoring Committee	No
Responsible Party	Haakon E. Meyer, University of Oslo
Study Sponsor ^ICMJE	University of Oslo
Collaborators ^ICMJE	Norwegian Institute of Public Health Hormone Laboratory, Aker University Hospital, Oslo, Norway Norwegian Foundation for Health and Rehabilitation
Investigators ^ICMJE	Not Provided
Information Provided By	University of Oslo
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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