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
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Fish oil capsule (specially manufactured for the study)
Dietary Supplement: Multivitamin tablet of type: Vitaplex ABCD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 74
Study Start Date: February 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fish oil capsule 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.
Experimental: Multivitamin tablet 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01482689

Locations
Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Norwegian Institute of Public Health
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Norwegian Foundation for Health and Rehabilitation
  More Information

Publications:
Responsible Party: Haakon E. Meyer, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01482689     History of Changes
Other Study ID Numbers: S-04340
Study First Received: November 23, 2011
Last Updated: November 28, 2011
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Social Science Data Services

Keywords provided by University of Oslo:
Bioavailability
Vitamin D metabolism
Bone turnover

Additional relevant MeSH terms:
Vitamin D
Vitamins
Cod Liver Oil
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014