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

NCT01482689 | Completed

• 1 other identifier: S-04340
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability; Vitamin D metabolism; Bone turnover

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

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

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

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

• 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

• 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

• 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

Study Arms (2)

Fish oil capsule

EXPERIMENTAL

Dietary Supplement: Fish oil capsule (specially manufactured for the study)

Multivitamin tablet

EXPERIMENTAL

Dietary Supplement: Multivitamin tablet of type: Vitaplex ABCD

Interventions

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.

Fish oil capsule

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.

Also known as: Vitaplex ABCD

Multivitamin tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to meet at baseline and follow-up visit

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Publications (2)

• 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. doi: 10.1017/S000711450773074X. Epub 2007 Apr 24.

  PMID: 17456248 RESULT

• Holvik K, Madar AA, Meyer HE, Lofthus CM, Stene LC. Changes in the vitamin D endocrine system and bone turnover after oral vitamin D3 supplementation in healthy adults: results of a randomised trial. BMC Endocr Disord. 2012 Jun 13;12:7. doi: 10.1186/1472-6823-12-7.

  PMID: 22695105 DERIVED

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 30, 2011
• Study Start: February 1, 2005
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: November 30, 2011

Record last verified: 2011-11

Locations

NO (1)