HealthyNCT03286673
Comparison of Three Calcium Supplements
A study testing calcium phosphate, Tricalcium Phosphate and Calcium carbonate in people with Healthy, run by University of Jena.
Trial summary
The study was conducted to investigate the metabolic effects of three different calcium compounds in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- calcium phosphate, Tricalcium Phosphate and Calcium carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 - 40 years
Who cannot join
- diseases of the gastrointestinal tract
- pregnancy
- the intake of any medication (e. g. for thyroid gland)
- intake of dietary supplements
About this study
Official title: Comparison of Three Calcium Supplements With Regard to Their Metabolic Effects in Healthy Adults
The study was conducted to investigate the metabolic effects of three different calcium compounds in healthy adults.
- Conditions
- Healthy
- Being tested
- calcium phosphate, Tricalcium Phosphate, Calcium carbonate, Placebo
- Keywords
- calcium carbonate, calcium phosphate, metabolic effects, human study, calcium and phosphorus metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium phosphateDietary supplement
Tricalcium PhosphateDietary supplement
Calcium carbonateDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| calcium phosphate | Experimental | Pentacalcium hydroxy-triphosphate (Ca5(PO4)3OH) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d. Receives: Dietary Supplement: calcium phosphate |
| Tricalcium Phosphate | Experimental | β-tricalcium phosphate (Ca3(PO4)2) as incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d. Receives: Dietary Supplement: Tricalcium Phosphate |
| Calcium carbonate | Experimental | Calcium carbonate (CaCO3) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d. Receives: Dietary Supplement: Calcium carbonate |
| Placebo | Active comparator | Wholemeal and crispy wafer bread without additional calcium additive. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum mineral concentration
Calcium and Phosphate (and others) concentration in serum.
Measured: after 4 weeks of each intervention
Stool mineral concentration
Calcium and Phosphate concentration (and others) in stool from a three day stool collection
Measured: after 4 weeks of each intervention
Urine mineral concentration
Calcium and Phosphate concentration (and others) in urine from a three day urine collection
Measured: after 4 weeks of each intervention
Lipids in blood
Lipids and lipoprotein concentration in serum.
Measured: after 4 weeks of each intervention
Sterols
Neutrals sterols and bile acids in stool from a three day stool collection
Measured: after 4 weeks of each intervention
Dietary intake
Evaluation of the dietary intake using a three day weighed dietary record.
Measured: after 4 weeks of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startOct 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286673
- Sponsor's protocol ID
- H28-06
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Calcium Supplements With Regard to Their Metabolic Effects in Healthy Adults
- ClinicalTrials.gov ID
- NCT03286673
- Acronym / sponsor ID
- H28-06
- Conditions
- Healthy
- Keywords
- calcium carbonate, calcium phosphate, metabolic effects, human study, calcium and phosphorus metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Oct 2006 (actual)
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 18 Sep 2017 (actual)
- 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 metabolic effects of three different calcium compounds in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| calcium phosphate | Experimental | Dietary Supplement: calcium phosphatePentacalcium hydroxy-triphosphate (Ca5(PO4)3OH) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d. |
| Tricalcium Phosphate | Experimental | Dietary Supplement: Tricalcium Phosphateβ-tricalcium phosphate (Ca3(PO4)2) as incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d. |
| Calcium carbonate | Experimental | Dietary Supplement: Calcium carbonateCalcium carbonate (CaCO3) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d. |
| Placebo | Active comparator | Dietary Supplement: PlaceboWholemeal and crispy wafer bread without additional calcium additive. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18 - 40 years
Key exclusion criteria (4 listed)
- diseases of the gastrointestinal tract
- pregnancy
- the intake of any medication (e. g. for thyroid gland)
- 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 phosphate | Dietary supplement | calcium phosphate |
| Tricalcium Phosphate | Dietary supplement | Tricalcium Phosphate |
| Calcium carbonate | Dietary supplement | Calcium carbonate |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Serum mineral concentration
Time frame: after 4 weeks of each intervention
Calcium and Phosphate (and others) concentration in serum.
Stool mineral concentration
Time frame: after 4 weeks of each intervention
Calcium and Phosphate concentration (and others) in stool from a three day stool collection
Urine mineral concentration
Time frame: after 4 weeks of each intervention
Calcium and Phosphate concentration (and others) in urine from a three day urine collection
Lipids in blood
Time frame: after 4 weeks of each intervention
Lipids and lipoprotein concentration in serum.
Sterols
Time frame: after 4 weeks of each intervention
Neutrals sterols and bile acids in stool from a three day stool collection
Dietary intake
Time frame: after 4 weeks of each intervention
Evaluation of the dietary intake using a three day weighed dietary record.
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 18 Sep 2017.
- Individual participant dataSharing planned: No
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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
Questions about this trial
What is this clinical trial studying?
A study testing calcium phosphate, Tricalcium Phosphate and Calcium carbonate in people with Healthy, run by University of Jena.
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 4 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Serum mineral concentration (time frame: after 4 weeks of each intervention). The study lists 6 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 18 Sep 2017.