OsteoporosisNCT02615301
Dietary Intake of Salmon and Bone Health
A study testing Tailor-made salmon with high levels of vitamin D3 and K1, Tailor-made salmon with low levels of vitamin D3 and high K1 and Tailor-made salmon with high levels of vitamin D3 and low K1 in people with Osteoporosis, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.
Trial summary
The aims of this study were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status, as well as body composition and bone mineral density. The 122 healthy postmenopausal women included in this 12 weeks intervention study were randomized into four groups: three salmon groups (with… Read more about this study
- Who is it for?
- Ages 50 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Tailor-made salmon with high levels of vitamin D3 and K1, Tailor-made salmon with low levels of vitamin D3 and high K1 and Tailor-made salmon with high levels of vitamin D3 and low K1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2009to Jun 2009
- 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 50 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postmenopausal women
- Caucasian ethnicity
- Age range 50-65 years
- Having postmenopausal age of at least one year
Who cannot join
- Osteoporotic fractures
- Medical treatment for osteoporosis
- Warfarin treatment
- Creatinine above or below normal range
- Hypervitaminosis D
- Malabsorption syndrome
Show all 9Show fewer
- Inflammatory bowel disease
- Inflammatory rheumatic diseases
- Women who had planned to go away on holiday during the intervention could not participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study
The aims of this study were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status, as well as body composition and bone mineral density. The 122 healthy postmenopausal women included in this 12 weeks intervention study were randomized into four groups: three salmon groups (with three different vitamin D3/vitamin K1 combinations) and one tablet group (vitamin D and Calcium).
Read the detailed description
Suboptimal vitamin D status is common among humans, and might have a negative impact on bone health. Fatty fish, including Atlantic salmon, is an important dietary vitamin D source. However, due to a considerable change in fish feed composition, the contribution of vitamin D from salmon fillet has been reduced. The aims were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density (BMD). The 122 healthy postmenopausal women (median 55 years) included in this 12 weeks intervention study were randomized into four groups: three salmon groups (150 grams/two times/week) and one tablet group (800IU vitamin D and 1000 mg Calcium/day). The salmon groups also received calcium supplements (1000 mg/d). The salmon had three different vitamin D3/vitamin K1 combinations: high D3 + high K1, low D3 + high K1, or high D3 + low K1.
- Conditions
- Osteoporosis
- Being tested
- Tailor-made salmon with high levels of vitamin D3 and K1, Tailor-made salmon with low levels of vitamin D3 and high K1, Tailor-made salmon with high levels of vitamin D3 and low K1, Supplement with vitamin D and Calcium
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailor-made salmon with high levels of vitamin D3 and K1Dietary supplement
The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
Tailor-made salmon with low levels of vitamin D3 and high K1Dietary supplement
The aims were to investigate how intake of tailor-made salmon with low levels of vitamin D3 and high K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
Tailor-made salmon with high levels of vitamin D3 and low K1Dietary supplement
The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and low K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
Supplement with vitamin D and CalciumDietary supplement
The aims were to investigate how supplement with vitamin D and Calcium affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
| Study group | Role | What they receive |
|---|---|---|
| Salmon (HD+HK) | Experimental | Tailor-made salmon with high levels of vitamin D3 and K1 Receives: Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and K1 |
| Salmon (LD+HK) | Experimental | Tailor-made salmon with low levels of vitamin D3 and high K1 Receives: Dietary Supplement: Tailor-made salmon with low levels of vitamin D3 and high K1 |
| Salmon (HD+LK) | Experimental | Tailor-made salmon with high levels of vitamin D3 and low K1 Receives: Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and low K1 |
| Supplement (vitamin D + Calcium) | Experimental | Supplement with vitamin D and Calcium Receives: Dietary Supplement: Supplement with vitamin D and Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone-specific alkaline phosphatase
Serum (µg/l)
Measured: 3 months
Osteocalcin
Serum (ng/ml)
Measured: 3 months
Undercarboxylated osteocalcin (GLU)
Serum (ng/ml)
Measured: 3 months
Carboxylated osteocalcine (GLA)
Serum (ng/ml)
Measured: 3 months
GLU/GLA-ratio
Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine
Measured: 3 months
N-telopeptides/creatinine
Urinary (mmol/l)
Measured: 3 months
Deoxypyridinoline/creatinine
Urinary (mmol/l)
Measured: 3 months
Secondary outcomes (6)
25-hyroxyvitamin D
Serum 25(OH)D (nmol/L)
Measured: 3 months
Eicosapentaenoic acids
Fatty acids composition of total red blood cells
Measured: 3 months
Docosahexaenoic acids
Fatty acids composition of total red blood cells
Measured: 3 months
Omega-3 index
The content of Eicosapentaenoic acids and Docosahexaenoic acids in red blood cell membranes expressed as percent of total fatty acids.
Measured: 3 months
Body composition
Total body soft tissue composition (fat mass and lean mass) measurements were performed using dual-energy X-ray absorptiometry (DXA) on a stationary fan beam densitometer.
Measured: 3 months
Bone mineral density
The total body bone mineral density (BMD) measurements were performed using dual-energy X-ray absorptiometry (DXA) on a stationary fan beam densitometer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nutrition and Seafood Research, Norway
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Jannike Øyen, National Institute of Nutrition and Seafood Research, Norway
- Investigators
- Ingvild E Graff, PhD, Study chair, NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615301
- Sponsor's protocol ID
- 252.07
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT02615301
- Acronym / sponsor ID
- 252.07
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- National Institute of Nutrition and Seafood Research, NorwayOther government
- Collaborators
- Haukeland University Hospital
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Nov 2015 (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 aims of this study were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status, as well as body composition and bone mineral density. The 122 healthy postmenopausal women included in this 12 weeks intervention study were randomized into four groups: three salmon groups (with three different vitamin D3/vitamin K1 combinations) and one tablet group (vitamin D and Calcium).
Detailed description
Suboptimal vitamin D status is common among humans, and might have a negative impact on bone health. Fatty fish, including Atlantic salmon, is an important dietary vitamin D source. However, due to a considerable change in fish feed composition, the contribution of vitamin D from salmon fillet has been reduced. The aims were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density (BMD). The 122 healthy postmenopausal women (median 55 years) included in this 12 weeks intervention study were randomized into four groups: three salmon groups (150 grams/two times/week) and one tablet group (800IU vitamin D and 1000 mg Calcium/day). The salmon groups also received calcium supplements (1000 mg/d). The salmon had three different vitamin D3/vitamin K1 combinations: high D3 + high K1, low D3 + high K1, or high D3 + low K1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salmon (HD+HK) | Experimental | Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and K1Tailor-made salmon with high levels of vitamin D3 and K1 |
| Salmon (LD+HK) | Experimental | Dietary Supplement: Tailor-made salmon with low levels of vitamin D3 and high K1Tailor-made salmon with low levels of vitamin D3 and high K1 |
| Salmon (HD+LK) | Experimental | Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and low K1Tailor-made salmon with high levels of vitamin D3 and low K1 |
| Supplement (vitamin D + Calcium) | Experimental | Dietary Supplement: Supplement with vitamin D and CalciumSupplement with vitamin D and Calcium |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Postmenopausal women
- Caucasian ethnicity
- Age range 50-65 years
- Having postmenopausal age of at least one year
Key exclusion criteria (9 listed)
- Osteoporotic fractures
- Medical treatment for osteoporosis
- Warfarin treatment
- Creatinine above or below normal range
- Hypervitaminosis D
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 |
|---|---|---|
| Tailor-made salmon with high levels of vitamin D3 and K1The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density. | Dietary supplement | Salmon (HD+HK) |
| Tailor-made salmon with low levels of vitamin D3 and high K1The aims were to investigate how intake of tailor-made salmon with low levels of vitamin D3 and high K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density. | Dietary supplement | Salmon (LD+HK) |
| Tailor-made salmon with high levels of vitamin D3 and low K1The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and low K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density. | Dietary supplement | Salmon (HD+LK) |
| Supplement with vitamin D and CalciumThe aims were to investigate how supplement with vitamin D and Calcium affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density. | Dietary supplement | Supplement (vitamin D + Calcium) |
Primary outcome
Bone-specific alkaline phosphatase
Time frame: 3 months
Serum (µg/l)
Osteocalcin
Time frame: 3 months
Serum (ng/ml)
Undercarboxylated osteocalcin (GLU)
Time frame: 3 months
Serum (ng/ml)
Carboxylated osteocalcine (GLA)
Time frame: 3 months
Serum (ng/ml)
GLU/GLA-ratio
Time frame: 3 months
Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine
N-telopeptides/creatinine
Time frame: 3 months
Urinary (mmol/l)
Deoxypyridinoline/creatinine
Time frame: 3 months
Urinary (mmol/l)
6 secondary outcomes
25-hyroxyvitamin D
Time frame: 3 months
Eicosapentaenoic acids
Time frame: 3 months
Docosahexaenoic acids
Time frame: 3 months
Omega-3 index
Time frame: 3 months
Body composition
Time frame: 3 months
Bone mineral density
Time frame: 3 months
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 26 Nov 2015.
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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.
Ingvild E Graff, PhD study chair
NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailor-made salmon with high levels of vitamin D3 and K1, Tailor-made salmon with low levels of vitamin D3 and high K1 and Tailor-made salmon with high levels of vitamin D3 and low K1 in people with Osteoporosis, run by National Institute of Nutrition and Seafood Research, Norway 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 4 inclusion and 9 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 26 Nov 2015. 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?
Bone-specific alkaline phosphatase (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2015.