HealthyNCT01482689
Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
A study testing Fish oil capsule (specially manufactured for the study) and Multivitamin tablet of type: Vitaplex ABCD in people with Healthy, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fish oil capsule (specially manufactured for the study) and Multivitamin tablet of type: Vitaplex ABCD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2005to Apr 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to meet at baseline and follow-up visit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Fish oil capsule (specially manufactured for the study), Multivitamin tablet of type: Vitaplex ABCD
- Keywords
- Bioavailability, Vitamin D metabolism, Bone turnover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ABCDDietary supplement
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Fish oil capsule | Experimental | Not described Receives: Dietary Supplement: Fish oil capsule (specially manufactured for the study) |
| Multivitamin tablet | Experimental | Not described Receives: Dietary Supplement: Multivitamin tablet of type: Vitaplex ABCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups
Measured: 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
Measured: 4 weeks (28 days) between baseline and follow-up visit
Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups
Measured: 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)
Measured: 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)
Measured: 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
Measured: 4 weeks (28 days) between baseline and follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startFeb 2005
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Hormone Laboratory, Aker University Hospital, Oslo, Norway, Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Haakon E. Meyer, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482689
- Sponsor's protocol ID
- S-04340
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17456248Holvik 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.
PubMed 22695105
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
- ClinicalTrials.gov ID
- NCT01482689
- Acronym / sponsor ID
- S-04340
- Conditions
- Healthy
- Keywords
- Bioavailability, Vitamin D metabolism, Bone turnover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Hormone Laboratory, Aker University Hospital, Oslo, Norway, Norwegian Foundation for Health and Rehabilitation
- Study start
- Feb 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be able to meet at baseline and follow-up visit
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Fish oil capsule |
| Multivitamin tablet of type: Vitaplex ABCDAlso: Vitaplex ABCDOne 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. | Dietary supplement | Multivitamin tablet |
Primary outcome
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
5 secondary outcomes
Difference in delta 25-hydroxyvitamin D (nmol/l) between men and women
Time frame: 4 weeks (28 days) between baseline and follow-up visit
Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups
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 intact parathyroid hormone (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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
- Results publication: PubMed 17456248Holvik 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.
- Derived from this study: PubMed 22695105Holvik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil capsule (specially manufactured for the study) and Multivitamin tablet of type: Vitaplex ABCD in people with Healthy, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01482689, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.