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Effects of Soluble Phosphate in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02095392
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Michael Glei, University of Jena

Study Description
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Brief 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. 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.

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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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]


Outcome Measures
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Primary Outcome Measures :
  1. Fasting phosphate concentration in blood [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
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Principal Investigator: Michael Glei, Prof. Dr. Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Prof. Dr. Michael Glei, University of Jena:
soluble phosphate
phosphorus metabolism
calcium metabolism
bone metabolism
human study