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Completed

NCT Number: NCT01482689

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish oil capsule (specially manufactured for the study)

Dietary Supplement

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.

Multivitamin tablet of type: Vitaplex ABCD

Dietary Supplement

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 names: Vitaplex ABCD

Primary outcomes

  1. 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

  1. Difference in delta 25-hydroxyvitamin D (nmol/l) between men and women

    Time frame: 4 weeks (28 days) between baseline and follow-up visit

  2. Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups

    Time frame: 4 weeks (28 days) between baseline and follow-up visit

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Hormone Laboratory, Aker University Hospital, Oslo, Norway
  • Norwegian Foundation for Health and Rehabilitation
  • Norwegian Institute of Public Health

Registry information

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Nov 30, 2011
Registry last updated
Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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