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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482689
• Other study ID #: S-04340
• Status: Completed
• Phase: N/A
• First received: November 23, 2011
• Last updated: November 28, 2011
• Start date: February 2005
• Est. completion date: April 2005

Study information

• Verified date: November 2011
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (4)

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

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 yo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups		4 weeks (28 days) between baseline and follow-up visit	No
Secondary	Difference in delta 25-hydroxyvitamin D (nmol/l) between men and women		4 weeks (28 days) between baseline and follow-up visit	No
Secondary	Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups		4 weeks (28 days) between baseline and follow-up visit	No
Secondary	Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum intact parathyroid hormone (pmol/l)		4 weeks (28 days) between baseline and follow-up visit	No
Secondary	Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum 1,25-dihydroxyvitamin D (pmol/l)		4 weeks (28 days) between baseline and follow-up visit
Secondary	Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum osteoclast-specific tartrate-resistant acid phosphatase (TRACP 5b); U/l		4 weeks (28 days) between baseline and follow-up visit