Healthy SubjectsNCT01297023
Human Intervention Study With Calcium Phosphate and Vitamin D
A study testing calcium phosphate, vitamin d and calcium phosphate and vitamin d in people with Healthy Subjects, run by University of Jena at 1 site in Germany.
Trial summary
The study was conducted to investigate the effect of vitamin d3 alone and in combination with calcium phosphate on bone metabolism and further physiological parameters in healthy subjects. It is postulated that calcium phosphate beneficially influences the bone specific action of vitamin d3. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- calcium phosphate, vitamin d and calcium phosphate and vitamin d
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to May 2011
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
Who cannot join
- pregnancy, lactation
- intake of dietary supplements
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, 07743
About this study
Official title: The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults
The study was conducted to investigate the effect of vitamin d3 alone and in combination with calcium phosphate on bone metabolism and further physiological parameters in healthy subjects. It is postulated that calcium phosphate beneficially influences the bone specific action of vitamin d3.
- Conditions
- Healthy Subjects
- Being tested
- calcium phosphate, vitamin d, calcium phosphate and vitamin d, placebo
- Keywords
- calcium phosphate, vitamin d3, bone metabolism, human study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium phosphateDietary supplement
20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]
vitamin dDietary supplement
20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d]
calcium phosphate and vitamin dDietary supplement
20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] and vitamin d3 (10µg/d]
placeboOther
All participants consume two weeks before intervention a bread without calcium an vitamin d.
| Study group | Role | What they receive |
|---|---|---|
| calcium phosphate | Experimental | Not described Receives: Dietary Supplement: calcium phosphate |
| vitamin d | Experimental | Not described Receives: Dietary Supplement: vitamin d |
| calcium phosphate and vitamin d | Experimental | Not described Receives: Dietary Supplement: calcium phosphate and vitamin d |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone resorption and bone formation markers in blood and urine
Measured: 8 weeks
Secondary outcomes (2)
concentration of minerals in blood, stool and urine
Measured: 8 weeks
blood lipids
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297023
- Sponsor's protocol ID
- LSEP H47-11
- Status last verified
- Nov 2012
- First submitted
- 15 Feb 2011
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trautvetter U, Neef N, Leiterer M, Kiehntopf M, Kratzsch J, Jahreis G. Effect of calcium phosphate and vitamin D(3) supplementation on bone remodelling and metabolism of calcium, phosphorus, magnesium and iron. Nutr J. 2014 Jan 17;13:6. doi: 10.1186/1475-2891-13-6.
PubMed 24438153
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults
- ClinicalTrials.gov ID
- NCT01297023
- Acronym / sponsor ID
- LSEP H47-11
- Conditions
- Healthy Subjects
- Keywords
- calcium phosphate, vitamin d3, bone metabolism, human study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Feb 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 study was conducted to investigate the effect of vitamin d3 alone and in combination with calcium phosphate on bone metabolism and further physiological parameters in healthy subjects. It is postulated that calcium phosphate beneficially influences the bone specific action of vitamin d3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| calcium phosphate | Experimental | Dietary Supplement: calcium phosphate |
| vitamin d | Experimental | Dietary Supplement: vitamin d |
| calcium phosphate and vitamin d | Experimental | Dietary Supplement: calcium phosphate and vitamin d |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (2 listed)
- pregnancy, lactation
- intake of dietary supplements
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 phosphate20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] | Dietary supplement | calcium phosphate |
| vitamin d20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d] | Dietary supplement | vitamin d |
| calcium phosphate and vitamin d20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] and vitamin d3 (10µg/d] | Dietary supplement | calcium phosphate and vitamin d |
| placeboAll participants consume two weeks before intervention a bread without calcium an vitamin d. | Other | placebo |
Primary outcome
bone resorption and bone formation markers in blood and urine
Time frame: 8 weeks
2 secondary outcomes
concentration of minerals in blood, stool and urine
Time frame: 8 weeks
blood lipids
Time frame: 8 weeks
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 7 Nov 2012.
- Derived from this study: PubMed 24438153Trautvetter U, Neef N, Leiterer M, Kiehntopf M, Kratzsch J, Jahreis G. Effect of calcium phosphate and vitamin D(3) supplementation on bone remodelling and metabolism of calcium, phosphorus, magnesium and iron. Nutr J. 2014 Jan 17;13:6. doi: 10.1186/1475-2891-13-6.
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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.
Gerhard Jahreis, Prof. Dr. principal investigator
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium phosphate, vitamin d and calcium phosphate and vitamin d in people with Healthy Subjects, run by University of Jena 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 1 inclusion and 2 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 7 Nov 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?
bone resorption and bone formation markers in blood and urine (time frame: 8 weeks). 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 NCT01297023, which also lists 1 linked publication.
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 7 Nov 2012.