Effects of Soluble Phosphate in Humans
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ClinicalTrials.gov Identifier: NCT02095392 |
Recruitment Status :
Completed
First Posted : March 24, 2014
Last Update Posted : December 2, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Dietary Supplement: P1000/Ca0 Dietary Supplement: P1000/Ca500 Dietary Supplement: P1000/Ca1000 Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: P1000/Ca0 |
Dietary Supplement: P1000/Ca0
22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d] Dietary Supplement: Placebo all participants consume two weeks before intervention the beverage without phosphate and calcium |
Experimental: P1000/Ca500 |
Dietary Supplement: P1000/Ca500
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium] Dietary Supplement: Placebo all participants consume two weeks before intervention the beverage without phosphate and calcium |
Experimental: P1000/Ca1000 |
Dietary Supplement: P1000/Ca1000
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium] Dietary Supplement: Placebo all participants consume two weeks before intervention the beverage without phosphate and calcium |
Placebo Comparator: Placebo |
Dietary Supplement: P1000/Ca0
22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d] Dietary Supplement: P1000/Ca500 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium] Dietary Supplement: P1000/Ca1000 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium] |
- Fasting phosphate concentration in blood [ Time Frame: 8 weeks ]
- Calcium and phosphorus metabolism [ Time Frame: 8 weeks ]
- 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

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age between 18-60 years
- physical health
Exclusion Criteria:
- postmenopausal women
- kidney diseases
- diabetes mellitus
- metabolic diseases
- osteoporosis
- intake of dietary supplements
- pregnancy and lactation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095392
Germany | |
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology | |
Jena, Thuringia, Germany, 07743 |
Principal Investigator: | Michael Glei, Prof. Dr. | Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology |
Responsible Party: | Prof. Dr. Michael Glei, Prof. Dr., University of Jena |
ClinicalTrials.gov Identifier: | NCT02095392 |
Other Study ID Numbers: |
H55-14 |
First Posted: | March 24, 2014 Key Record Dates |
Last Update Posted: | December 2, 2015 |
Last Verified: | November 2015 |
soluble phosphate phosphorus metabolism calcium metabolism bone metabolism human study |