Vitamin D DeficiencyNCT01696526
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish
A study testing vitamin D fortified fish and conventional fish in people with Vitamin D Deficiency, run by Ulrike Lehmann at 1 site in Germany.
Trial summary
The aim of this study is to investigate the bioavailability of conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D fortified fish and conventional fish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Dec 2012
- 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
- 18 years
- healthy
Who cannot join
- supplementation of vitamin d and calcium
- hypercalcemia
- hypercalciuria
- chronical illness (diabetes, kidney diseases, cardiovascular diseases)
- serum-creatinine above 115 mmol/l
- pregnancy or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers
The aim of this study is to investigate the bioavailability of conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.
Read the detailed description
Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum.
Groups/Cohorts Assigned Interventions
- Placebo group receiving conventional fish
- intervention group receiving vitamin D fortified fish
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D fortified fish, conventional fish
- Keywords
- vitamin D, bioeffiency, vitamin d fortified fish
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D fortified fishOther
Also called intervention
fish containing vitamin D3
conventional fishOther
Also called placebo
fish containing low concentrations of vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| vitamin D fortified fish | Experimental | Human volunteers receiving vitamin D fortified fish, 4 weeks Receives: Other: vitamin D fortified fish |
| conventional fish | Placebo comparator | consumption of conventional fish , 4 weeks Receives: Other: conventional fish |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of 25-hydroxvitamin D
Measured: after 4 weeks of consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrike Lehmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gabriele I. Stangl, Prof., Study director, Institut für Agrar- und Ernährungswissenschaften
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696526
- Sponsor's protocol ID
- BMBF 0315668
- Status last verified
- Dec 2012
- First submitted
- 27 Sep 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01696526
- Acronym / sponsor ID
- BMBF 0315668
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, bioeffiency, vitamin d fortified fish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ulrike LehmannUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Oct 2012 (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 aim of this study is to investigate the bioavailability of conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.
Detailed description
Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum.
Groups/Cohorts Assigned Interventions
- Placebo group receiving conventional fish
- intervention group receiving vitamin D fortified fish
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D fortified fish | Experimental | Other: vitamin D fortified fishHuman volunteers receiving vitamin D fortified fish, 4 weeks |
| conventional fish | Placebo comparator | Other: conventional fishconsumption of conventional fish , 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years
- healthy
Key exclusion criteria (6 listed)
- supplementation of vitamin d and calcium
- hypercalcemia
- hypercalciuria
- chronical illness (diabetes, kidney diseases, cardiovascular diseases)
- serum-creatinine above 115 mmol/l
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 |
|---|---|---|
| vitamin D fortified fishAlso: interventionfish containing vitamin D3 | Other | vitamin D fortified fish |
| conventional fishAlso: placebofish containing low concentrations of vitamin D3 | Other | conventional fish |
Primary outcome
change of 25-hydroxvitamin D
Time frame: after 4 weeks of consumption
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 Dec 2012.
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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.
Gabriele I. Stangl, Prof. study director
Institut für Agrar- und Ernährungswissenschaften
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D fortified fish and conventional fish in people with Vitamin D Deficiency, run by Ulrike Lehmann at 1 site in Germany.
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 2 inclusion and 6 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 Dec 2012. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
change of 25-hydroxvitamin D (time frame: after 4 weeks of consumption). 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 Dec 2012.