Healthy VolunteersNCT02095392
Effects of Soluble Phosphate in Humans
A study testing P1000/Ca0, P1000/Ca500 and P1000/Ca1000 in people with Healthy Volunteers, run by University of Jena at 1 site in Germany.
Trial summary
The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- P1000/Ca0, P1000/Ca500 and P1000/Ca1000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Jul 2014
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18-60 years
- physical health
Who cannot join
- postmenopausal women
- kidney diseases
- diabetes mellitus
- metabolic diseases
- osteoporosis
- intake of dietary supplements
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology
Jena, Thuringia, 07743
About this study
Official title: The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults
The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.
- Conditions
- Healthy Volunteers
- Being tested
- P1000/Ca0, P1000/Ca500, P1000/Ca1000, Placebo
- Keywords
- soluble phosphate, phosphorus metabolism, calcium metabolism, bone metabolism, human study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1000/Ca0Dietary supplement
22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]
P1000/Ca500Dietary supplement
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]
P1000/Ca1000Dietary supplement
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]
PlaceboDietary supplement
all participants consume two weeks before intervention the beverage without phosphate and calcium
| Study group | Role | What they receive |
|---|---|---|
| P1000/Ca0 | Experimental | Not described Receives: Dietary Supplement: P1000/Ca0; Dietary Supplement: Placebo |
| P1000/Ca500 | Experimental | Not described Receives: Dietary Supplement: P1000/Ca500; Dietary Supplement: Placebo |
| P1000/Ca1000 | Experimental | Not described Receives: Dietary Supplement: P1000/Ca1000; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: P1000/Ca0; Dietary Supplement: P1000/Ca500; Dietary Supplement: P1000/Ca1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting phosphate concentration in blood
Measured: 8 weeks
Secondary outcomes (1)
Calcium and phosphorus metabolism
- parameters of phosphate and calcium metabolism (1,25-OHD; 25-OHD;FGF23;PTH)
- parameters of bone formation and resorption (osteocalcin, P1NP, CTX)
- minerals in plasma, faeces and urine
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 posted24 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Michael Glei, University of Jena
- Investigators
- Michael Glei, Prof. Dr., Principal investigator, Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095392
- Sponsor's protocol ID
- H55-14
- Status last verified
- Nov 2015
- First submitted
- 17 Mar 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Trautvetter U, Camarinha-Silva A, Jahreis G, Lorkowski S, Glei M. High phosphorus intake and gut-related parameters - results of a randomized placebo-controlled human intervention study. Nutr J. 2018 Feb 16;17(1):23. doi: 10.1186/s12937-018-0331-4.
PubMed 29452584Trautvetter U, Jahreis G, Kiehntopf M, Glei M. Consequences of a high phosphorus intake on mineral metabolism and bone remodeling in dependence of calcium intake in healthy subjects - a randomized placebo-controlled human intervention study. Nutr J. 2016 Jan 19;15:7. doi: 10.1186/s12937-016-0125-5.
PubMed 26786148
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults
- ClinicalTrials.gov ID
- NCT02095392
- Acronym / sponsor ID
- H55-14
- Conditions
- Healthy Volunteers
- Keywords
- soluble phosphate, phosphorus metabolism, calcium metabolism, bone metabolism, human study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Mar 2014 (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 soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P1000/Ca0 | Experimental | Dietary Supplement: P1000/Ca0, Dietary Supplement: Placebo |
| P1000/Ca500 | Experimental | Dietary Supplement: P1000/Ca500, Dietary Supplement: Placebo |
| P1000/Ca1000 | Experimental | Dietary Supplement: P1000/Ca1000, Dietary Supplement: Placebo |
| Placebo | Placebo comparator | Dietary Supplement: P1000/Ca0, Dietary Supplement: P1000/Ca500, Dietary Supplement: P1000/Ca1000 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18-60 years
- physical health
Key exclusion criteria (7 listed)
- postmenopausal women
- kidney diseases
- diabetes mellitus
- metabolic diseases
- osteoporosis
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 |
|---|---|---|
| P1000/Ca022 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d] | Dietary supplement | P1000/Ca0, Placebo |
| P1000/Ca50022 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium] | Dietary supplement | P1000/Ca500, Placebo |
| P1000/Ca100022 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium] | Dietary supplement | P1000/Ca1000, Placebo |
| Placeboall participants consume two weeks before intervention the beverage without phosphate and calcium | Dietary supplement | P1000/Ca0, P1000/Ca1000, P1000/Ca500 |
Primary outcome
Fasting phosphate concentration in blood
Time frame: 8 weeks
1 secondary outcome
Calcium and phosphorus metabolism
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 2 Dec 2015.
- Derived from this study: PubMed 29452584Trautvetter U, Camarinha-Silva A, Jahreis G, Lorkowski S, Glei M. High phosphorus intake and gut-related parameters - results of a randomized placebo-controlled human intervention study. Nutr J. 2018 Feb 16;17(1):23. doi: 10.1186/s12937-018-0331-4.
- Derived from this study: PubMed 26786148Trautvetter U, Jahreis G, Kiehntopf M, Glei M. Consequences of a high phosphorus intake on mineral metabolism and bone remodeling in dependence of calcium intake in healthy subjects - a randomized placebo-controlled human intervention study. Nutr J. 2016 Jan 19;15:7. doi: 10.1186/s12937-016-0125-5.
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Screening Protocol
Pain
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.
Michael Glei, Prof. Dr. principal investigator
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P1000/Ca0, P1000/Ca500 and P1000/Ca1000 in people with Healthy Volunteers, 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 2 inclusion and 7 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 2 Dec 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 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?
Fasting phosphate concentration in blood (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 NCT02095392, which also lists 2 linked publications.
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 2 Dec 2015.