Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
This study has been completed.
Sponsor:
University of Oslo
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
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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
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:
|
Cod Liver Oil Vitamin D Ergocalciferols Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 23, 2013