Calcium MetabolismNCT00393289
Calcium Absorption and Retention From Marine Products
A study of Calcium Metabolism, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the study is to determine the uptake of calcium from fish bone meal from salmon and cod in 12 healthy volunteers. A test meal labelled with trace amounts of a radioactive calcium isotope (Ca47) will be given after an overnight fast and whole body retention of calcium will be measured on day 13, 21, and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Calcium Metabolism
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Mar 2007
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
- BMI: 18-18 kg/m2
- age: 18-40 years
Who cannot join
- elite athletes
- on medication
- gastrointestinal disorders, chronic diseaes
- smoking
- prior participation in radioisotpe studies
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Human Nutirtion, The Royal Veterinary and Agricultural University, Denmark
Frederiksberg, Frederiksberg C, 1958
About this study
The purpose of the study is to determine the uptake of calcium from fish bone meal from salmon and cod in 12 healthy volunteers. A test meal labelled with trace amounts of a radioactive calcium isotope (Ca47) will be given after an overnight fast and whole body retention of calcium will be measured on day 13, 21, and 24 after the test meal day.
Read the detailed description
Background:
Up till now little attention has been given the exploitation of marine by-products from the fishing industry. Calcium in fish is found mainly in bone and skin. By-products from these sources are limited to production of gelatine. Small fish, which can be eaten whole with bones included, are traditionally considered to be a good source of calcium. Until recently, bioavailability of this calcium was not known. Two recent studies from Denmark have shown that the absorption of calcium from small soft-boned fish was comparable to that of skimmed milk both in rats and in humans.
Calcium fortified foods are likely to play an important role in helping consumers to achieve calcium requirements aimed at reducing the risk of developing osteoporosis. Experimental evidence show a positive effect of calcium supplementation on bone mineral accretion in children, and combined calcium and vitamin D supplementation has resulted in reduced bone loss and fracture incidence in older men and women.
This protocol describes a project on the nutritional utilisation of calcium from fish bone waste. The main objective is to maximise the use and the added value of marine by-products with special emphasis on utilisation of fish bone as a calcium source and determine its bioavailabiliy in humans.
Study design :
This study will follow a 3x7 weeks ransomised crossover design, where the calcium absorption and retention will be measured form meals labelled with 47Ca. The test meals will be digested in the morning after a 12h fast and bloodsampling. Whole body retention will be measured on day 15, 22 and 26, and calibrated against a background measurement from the day prior to ingestion of the test meal. The subjects will receive an ordinary standardised diet for 2 days prior and 3 days after the test meals. This diet will be standardised to match the subjects' individual calcium intake.
Test meals:
Two types of fish bone meal (from salmon and cod fish) and a control (CaCO3) will be tested. Amounts equivalent of 800 mg Ca will be baked into bread, which will be labelled with 47Ca and served with 500 mL of ultra pure water at the department.
Isotopes and labelling procedure:
Isotopes (47Ca) will be ordered from Risø National Laboratory, Radiation Research Department, Denmark. The department of Human Nutrition will recieve the prepared doses of isotopes the day before the test meal. A dose of 0.2 MBq/ml will be used. The doses will be used to extrinsically label the test meals by drop-wise adding 1 ml of isotope solution in the afternoon on the day before intake of test meals and stored at 5 degree C until ingested.
Since each subject will recieve labelled meals on three occasions, a total dose of 0.6 MBq will be ingested during the study.
Measurement of calcium retention:
The whole body retention of calcium will be measured with a whole body counter at the Copenhagen University Hospital, Denmark. All measurements of calcium retention will be corrected for physical decay back to the time of administration.
Chemical analyses:
Serun calcium, phosphorus and vitamin D concentrations will be determined in before each test meal. Plasma levels of PTH will be determined before the first test meal only.
- Conditions
- Calcium Metabolism
- Being tested
- Calcium controlled diet
- Keywords
- Calcium absorption, D-vitamin status, Whole body calcium retention, Calcium intake, PTH status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium controlled dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body retention of calcium
Secondary outcomes (1)
D-vitamin and PTH status, serum calcium and phosporus, and calcium intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startNov 2005
- Primary completionApr 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium MetabolismStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nutrition and Seafood Research, Norway
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Susanne Bügel, MSc, PhD, Principal investigator, Institute of Human Nutrition, THe Royal Veterinary and Agricultural University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393289
- Sponsor's protocol ID
- KF-01270319
- Other IDs
- M182
- Status last verified
- Jul 2016
- First submitted
- 26 Oct 2006
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Absorption and Retention From Marine Products
- ClinicalTrials.gov ID
- NCT00393289
- Acronym / sponsor ID
- KF-01270319
- Conditions
- Calcium Metabolism
- Keywords
- Calcium absorption, D-vitamin status, Whole body calcium retention, Calcium intake, PTH status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- National Institute of Nutrition and Seafood Research, Norway
- Study start
- Nov 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Oct 2006 (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 purpose of the study is to determine the uptake of calcium from fish bone meal from salmon and cod in 12 healthy volunteers. A test meal labelled with trace amounts of a radioactive calcium isotope (Ca47) will be given after an overnight fast and whole body retention of calcium will be measured on day 13, 21, and 24 after the test meal day.
Detailed description
Background:
Up till now little attention has been given the exploitation of marine by-products from the fishing industry. Calcium in fish is found mainly in bone and skin. By-products from these sources are limited to production of gelatine. Small fish, which can be eaten whole with bones included, are traditionally considered to be a good source of calcium. Until recently, bioavailability of this calcium was not known. Two recent studies from Denmark have shown that the absorption of calcium from small soft-boned fish was comparable to that of skimmed milk both in rats and in humans.
Calcium fortified foods are likely to play an important role in helping consumers to achieve calcium requirements aimed at reducing the risk of developing osteoporosis. Experimental evidence show a positive effect of calcium supplementation on bone mineral accretion in children, and combined calcium and vitamin D supplementation has resulted in reduced bone loss and fracture incidence in older men and women.
This protocol describes a project on the nutritional utilisation of calcium from fish bone waste. The main objective is to maximise the use and the added value of marine by-products with special emphasis on utilisation of fish bone as a calcium source and determine its bioavailabiliy in humans.
Study design :
This study will follow a 3x7 weeks ransomised crossover design, where the calcium absorption and retention will be measured form meals labelled with 47Ca. The test meals will be digested in the morning after a 12h fast and bloodsampling. Whole body retention will be measured on day 15, 22 and 26, and calibrated against a background measurement from the day prior to ingestion of the test meal. The subjects will receive an ordinary standardised diet for 2 days prior and 3 days after the test meals. This diet will be standardised to match the subjects' individual calcium intake.
Test meals:
Two types of fish bone meal (from salmon and cod fish) and a control (CaCO3) will be tested. Amounts equivalent of 800 mg Ca will be baked into bread, which will be labelled with 47Ca and served with 500 mL of ultra pure water at the department.
Isotopes and labelling procedure:
Isotopes (47Ca) will be ordered from Risø National Laboratory, Radiation Research Department, Denmark. The department of Human Nutrition will recieve the prepared doses of isotopes the day before the test meal. A dose of 0.2 MBq/ml will be used. The doses will be used to extrinsically label the test meals by drop-wise adding 1 ml of isotope solution in the afternoon on the day before intake of test meals and stored at 5 degree C until ingested.
Since each subject will recieve labelled meals on three occasions, a total dose of 0.6 MBq will be ingested during the study.
Measurement of calcium retention:
The whole body retention of calcium will be measured with a whole body counter at the Copenhagen University Hospital, Denmark. All measurements of calcium retention will be corrected for physical decay back to the time of administration.
Chemical analyses:
Serun calcium, phosphorus and vitamin D concentrations will be determined in before each test meal. Plasma levels of PTH will be determined before the first test meal only.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males
- BMI: 18-18 kg/m2
- age: 18-40 years
Key exclusion criteria (5 listed)
- elite athletes
- on medication
- gastrointestinal disorders, chronic diseaes
- smoking
- prior participation in radioisotpe studies
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 |
|---|---|---|
| Calcium controlled diet | Behavioural | – |
Primary outcome
Whole body retention of calcium
1 secondary outcome
D-vitamin and PTH status, serum calcium and phosporus, and calcium intake
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 20 Jul 2016.
- Individual participant dataSharing planned: Yes
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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.
Susanne Bügel, MSc, PhD principal investigator
Institute of Human Nutrition, THe Royal Veterinary and Agricultural University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Calcium Metabolism, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 5 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 20 Jul 2016. 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 Denmark. 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?
Whole body retention of calcium. 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 20 Jul 2016.