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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

November 23, 2011
November 28, 2011
February 2005
April 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01482689 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Healthy
  • 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
  • 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
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.
 
Completed
74
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01482689
S-04340
No
Haakon E. Meyer, University of Oslo
University of Oslo
  • Norwegian Institute of Public Health
  • Hormone Laboratory, Aker University Hospital, Oslo, Norway
  • Norwegian Foundation for Health and Rehabilitation
Not Provided
University of Oslo
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP